literature review on guidance services

Guidance and counseling relations to high school students’ positive development and psychopathology: A non-recursive modeling study

• Published: 06 May 2021
• Volume 42 , pages 4609–4619, ( 2023 )

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• Qing Xiong 1 , 2 , 3 ,
• Xiaoyi Fang 1 , 2 ,
• Yang Wu 3 ,
• Haide Chen 4 ,
• Wei Hu 5 &
• Yuchi Zhang 6  

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School guidance and counseling services are important for adolescent development. This study focused on the predictive role of three main delivery strategies (guidance curriculum, group counseling, and individual counseling) on students’ positive development (academic, personal-social, career) and psychopathology (anxiety, depression, problem behaviors) in the high school context. Cross-sectional data were obtained from 59 high schools and 8556 students from mainland China. The results showed that the relationships between the number of times students attended guidance and counseling services and the domains of positive development were significantly higher than the relationship of the services with psychopathology. Furthermore, non-recursive model analyses showed that the latent variable of positive development mediated the influence of the services on psychopathology. In addition, psychopathology mediated the influence of counseling on positive development. The present findings confirm that school guidance and counseling services are effective for student development in China and provide partial support for the classification of guidance and counseling delivery strategies in terms of actual service effects. While paying attention to the differences in delivery strategies, school administrators are advised to consider the indirect effects of guidance and counseling on student development, which benefits the development and integration of comprehensive guidance services.

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The datasets generated during and/or analysed during the current study are not publicly available due ethical considerations but are available from the corresponding author on reasonable request.

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Funding for this study was provided by Key research projects of Humanities and Social Sciences of the Ministry of Education of the People’s Republic of China (No. 16JJD880009).

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Xiong, Q., Fang, X., Wu, Y. et al. Guidance and counseling relations to high school students’ positive development and psychopathology: A non-recursive modeling study. Curr Psychol 42 , 4609–4619 (2023). https://doi.org/10.1007/s12144-021-01722-7

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How to Write a Literature Review | Guide, Examples, & Templates

Published on January 2, 2023 by Shona McCombes . Revised on September 11, 2023.

What is a literature review? A literature review is a survey of scholarly sources on a specific topic. It provides an overview of current knowledge, allowing you to identify relevant theories, methods, and gaps in the existing research that you can later apply to your paper, thesis, or dissertation topic .

There are five key steps to writing a literature review:

• Search for relevant literature
• Evaluate sources
• Identify themes, debates, and gaps
• Outline the structure
• Write your literature review

A good literature review doesn’t just summarize sources—it analyzes, synthesizes , and critically evaluates to give a clear picture of the state of knowledge on the subject.

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What is the purpose of a literature review, examples of literature reviews, step 1 – search for relevant literature, step 2 – evaluate and select sources, step 3 – identify themes, debates, and gaps, step 4 – outline your literature review’s structure, step 5 – write your literature review, free lecture slides, other interesting articles, frequently asked questions, introduction.

• Quick Run-through
• Step 1 & 2

When you write a thesis , dissertation , or research paper , you will likely have to conduct a literature review to situate your research within existing knowledge. The literature review gives you a chance to:

• Demonstrate your familiarity with the topic and its scholarly context
• Develop a theoretical framework and methodology for your research
• Position your work in relation to other researchers and theorists
• Show how your research addresses a gap or contributes to a debate
• Evaluate the current state of research and demonstrate your knowledge of the scholarly debates around your topic.

Writing literature reviews is a particularly important skill if you want to apply for graduate school or pursue a career in research. We’ve written a step-by-step guide that you can follow below.

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Writing literature reviews can be quite challenging! A good starting point could be to look at some examples, depending on what kind of literature review you’d like to write.

• Example literature review #1: “Why Do People Migrate? A Review of the Theoretical Literature” ( Theoretical literature review about the development of economic migration theory from the 1950s to today.)
• Example literature review #2: “Literature review as a research methodology: An overview and guidelines” ( Methodological literature review about interdisciplinary knowledge acquisition and production.)
• Example literature review #3: “The Use of Technology in English Language Learning: A Literature Review” ( Thematic literature review about the effects of technology on language acquisition.)
• Example literature review #4: “Learners’ Listening Comprehension Difficulties in English Language Learning: A Literature Review” ( Chronological literature review about how the concept of listening skills has changed over time.)

You can also check out our templates with literature review examples and sample outlines at the links below.

Download Word doc Download Google doc

Before you begin searching for literature, you need a clearly defined topic .

If you are writing the literature review section of a dissertation or research paper, you will search for literature related to your research problem and questions .

Make a list of keywords

Start by creating a list of keywords related to your research question. Include each of the key concepts or variables you’re interested in, and list any synonyms and related terms. You can add to this list as you discover new keywords in the process of your literature search.

• Social media, Facebook, Instagram, Twitter, Snapchat, TikTok
• Body image, self-perception, self-esteem, mental health
• Generation Z, teenagers, adolescents, youth

Search for relevant sources

Use your keywords to begin searching for sources. Some useful databases to search for journals and articles include:

• Your university’s library catalogue
• Google Scholar
• Project Muse (humanities and social sciences)
• Medline (life sciences and biomedicine)
• EconLit (economics)
• Inspec (physics, engineering and computer science)

You can also use boolean operators to help narrow down your search.

Make sure to read the abstract to find out whether an article is relevant to your question. When you find a useful book or article, you can check the bibliography to find other relevant sources.

You likely won’t be able to read absolutely everything that has been written on your topic, so it will be necessary to evaluate which sources are most relevant to your research question.

For each publication, ask yourself:

• What question or problem is the author addressing?
• What are the key concepts and how are they defined?
• What are the key theories, models, and methods?
• Does the research use established frameworks or take an innovative approach?
• What are the results and conclusions of the study?
• How does the publication relate to other literature in the field? Does it confirm, add to, or challenge established knowledge?
• What are the strengths and weaknesses of the research?

Make sure the sources you use are credible , and make sure you read any landmark studies and major theories in your field of research.

You can use our template to summarize and evaluate sources you’re thinking about using. Click on either button below to download.

Take notes and cite your sources

As you read, you should also begin the writing process. Take notes that you can later incorporate into the text of your literature review.

It is important to keep track of your sources with citations to avoid plagiarism . It can be helpful to make an annotated bibliography , where you compile full citation information and write a paragraph of summary and analysis for each source. This helps you remember what you read and saves time later in the process.

To begin organizing your literature review’s argument and structure, be sure you understand the connections and relationships between the sources you’ve read. Based on your reading and notes, you can look for:

• Trends and patterns (in theory, method or results): do certain approaches become more or less popular over time?
• Themes: what questions or concepts recur across the literature?
• Debates, conflicts and contradictions: where do sources disagree?
• Pivotal publications: are there any influential theories or studies that changed the direction of the field?
• Gaps: what is missing from the literature? Are there weaknesses that need to be addressed?

This step will help you work out the structure of your literature review and (if applicable) show how your own research will contribute to existing knowledge.

• Most research has focused on young women.
• There is an increasing interest in the visual aspects of social media.
• But there is still a lack of robust research on highly visual platforms like Instagram and Snapchat—this is a gap that you could address in your own research.

There are various approaches to organizing the body of a literature review. Depending on the length of your literature review, you can combine several of these strategies (for example, your overall structure might be thematic, but each theme is discussed chronologically).

Chronological

The simplest approach is to trace the development of the topic over time. However, if you choose this strategy, be careful to avoid simply listing and summarizing sources in order.

Try to analyze patterns, turning points and key debates that have shaped the direction of the field. Give your interpretation of how and why certain developments occurred.

If you have found some recurring central themes, you can organize your literature review into subsections that address different aspects of the topic.

For example, if you are reviewing literature about inequalities in migrant health outcomes, key themes might include healthcare policy, language barriers, cultural attitudes, legal status, and economic access.

Methodological

If you draw your sources from different disciplines or fields that use a variety of research methods , you might want to compare the results and conclusions that emerge from different approaches. For example:

• Look at what results have emerged in qualitative versus quantitative research
• Discuss how the topic has been approached by empirical versus theoretical scholarship
• Divide the literature into sociological, historical, and cultural sources

Theoretical

A literature review is often the foundation for a theoretical framework . You can use it to discuss various theories, models, and definitions of key concepts.

You might argue for the relevance of a specific theoretical approach, or combine various theoretical concepts to create a framework for your research.

Like any other academic text , your literature review should have an introduction , a main body, and a conclusion . What you include in each depends on the objective of your literature review.

The introduction should clearly establish the focus and purpose of the literature review.

Depending on the length of your literature review, you might want to divide the body into subsections. You can use a subheading for each theme, time period, or methodological approach.

As you write, you can follow these tips:

• Summarize and synthesize: give an overview of the main points of each source and combine them into a coherent whole
• Analyze and interpret: don’t just paraphrase other researchers — add your own interpretations where possible, discussing the significance of findings in relation to the literature as a whole
• Critically evaluate: mention the strengths and weaknesses of your sources
• Write in well-structured paragraphs: use transition words and topic sentences to draw connections, comparisons and contrasts

In the conclusion, you should summarize the key findings you have taken from the literature and emphasize their significance.

When you’ve finished writing and revising your literature review, don’t forget to proofread thoroughly before submitting. Not a language expert? Check out Scribbr’s professional proofreading services !

This article has been adapted into lecture slides that you can use to teach your students about writing a literature review.

Scribbr slides are free to use, customize, and distribute for educational purposes.

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If you want to know more about the research process , methodology , research bias , or statistics , make sure to check out some of our other articles with explanations and examples.

• Sampling methods
• Simple random sampling
• Stratified sampling
• Cluster sampling
• Likert scales
• Reproducibility

 Statistics

• Null hypothesis
• Statistical power
• Probability distribution
• Effect size
• Poisson distribution

Research bias

• Optimism bias
• Cognitive bias
• Implicit bias
• Hawthorne effect
• Anchoring bias
• Explicit bias

A literature review is a survey of scholarly sources (such as books, journal articles, and theses) related to a specific topic or research question .

It is often written as part of a thesis, dissertation , or research paper , in order to situate your work in relation to existing knowledge.

There are several reasons to conduct a literature review at the beginning of a research project:

• To familiarize yourself with the current state of knowledge on your topic
• To ensure that you’re not just repeating what others have already done
• To identify gaps in knowledge and unresolved problems that your research can address
• To develop your theoretical framework and methodology
• To provide an overview of the key findings and debates on the topic

Writing the literature review shows your reader how your work relates to existing research and what new insights it will contribute.

The literature review usually comes near the beginning of your thesis or dissertation . After the introduction , it grounds your research in a scholarly field and leads directly to your theoretical framework or methodology .

A literature review is a survey of credible sources on a topic, often used in dissertations , theses, and research papers . Literature reviews give an overview of knowledge on a subject, helping you identify relevant theories and methods, as well as gaps in existing research. Literature reviews are set up similarly to other  academic texts , with an introduction , a main body, and a conclusion .

An  annotated bibliography is a list of  source references that has a short description (called an annotation ) for each of the sources. It is often assigned as part of the research process for a  paper .  

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The effect of corporate social responsibility on corporate performance in the food industry in saudi arabia: a partial least squares structural equation modeling approach.

1. Introduction

2. review of literature and hypothesis development, 2.1. csr and financial performance, 2.2. csr and competitive advantage, 2.3. csr and financial performance: the mediation role of innovation, 2.4. csr and competitive advantage: the mediation role of innovation, 2.5. csr and financial performance: the moderate role of competitive advantage, 3. methodology, 3.1. sample and data collection, 3.2. mathematical formulation of the model.

• - C S R : Corporate social responsibility;
• - I N N : Innovation;
• - C A : Competitive advantage;
• - F P : Financial performance.

3.3. Questionnaire Development

3.4. data analysis using pls-sem, 4. analysis and results, 4.1. common method bias, 4.2. assessment of the measurement model, 4.2.1. indicator reliability, 4.2.2. internal consistency reliability and convergent validity, 4.2.3. discriminant validity, 4.3. evaluation of the structural model, 4.3.1. assess collinearity issues within the model, 4.3.2. the significance and relevance of the model relationships, 4.3.3. examine the model’s explanatory power, 4.3.4. assess the model’s predictive power, 4.4. path analysis and hypotheses testing, 4.4.1. mediating effects, 4.4.2. moderating effect, 5. discussion of results, 6. conclusion remarks, author contributions, institutional review board statement, informed consent statement, data availability statement, acknowledgments, conflicts of interest.

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Share and Cite

Eledum, H.; Elmahgop, F.O. The Effect of Corporate Social Responsibility on Corporate Performance in the Food Industry in Saudi Arabia: A Partial Least Squares Structural Equation Modeling Approach. Sustainability 2024 , 16 , 7925. https://doi.org/10.3390/su16187925

Eledum H, Elmahgop FO. The Effect of Corporate Social Responsibility on Corporate Performance in the Food Industry in Saudi Arabia: A Partial Least Squares Structural Equation Modeling Approach. Sustainability . 2024; 16(18):7925. https://doi.org/10.3390/su16187925

Eledum, Hussein, and Faiza Omer Elmahgop. 2024. "The Effect of Corporate Social Responsibility on Corporate Performance in the Food Industry in Saudi Arabia: A Partial Least Squares Structural Equation Modeling Approach" Sustainability 16, no. 18: 7925. https://doi.org/10.3390/su16187925

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WHO and ITU publish new guidance to make telehealth services accessible

The World Health Organization (WHO) and the International Telecommunication Union (ITU) have published the Implementation toolkit for accessible telehealth services . This toolkit provides practical guidance to support governments, policymakers, health industry, health services providers, and civil society on how to integrate accessibility features in telehealth services.

The COVID-19 pandemic created an unprecedented need and galvanized the rapid development and scaling-up of telehealth services. Many governments and key partners are now investing in the development of telehealth services and their integration in mainstream health-care provision. Now is a critical time to think about how this digital transformation can be intentionally designed to benefit everyone and promote health for all.

Designing accessible telehealth services for persons with disabilities can be a game-changer to accelerate progress towards global health goals. It means unlocking access to telehealth for 1.3 billion people worldwide with a significant disability – representing 1 in 6 of us.

In the WHO Global report on health equity for persons with disabilities , the inaccessibility of telehealth services is listed among the known factors that hinder the fair access to health services for persons with disabilities. For example, persons with disabilities can be left out if telehealth platforms are not compatible with screen readers or Braille keyboards, do not provide captioning, or use a complicated user interface.

The WHO-ITU Global standard for accessibility of telehealth services , published in 2022, already provides the recommendations of accessibility features that must be used in telehealth services to address these barriers.

Building on this global standard, the new publication answers the question of how to go about the implementation process and advance health equity for persons with disabilities. It is a key tool to help all stakeholders consider and integrate accessibility in their existing strategic processes for telehealth service development.

“The proposed process is not about ‘doing more’, but rather about ‘doing smarter’,” said Darryl Barrett, WHO disability technical lead. “By consciously integrating accessibility from the early phases of telehealth strategic planning, we can build more sustainable health-care for all. It’s smarter in the sense that the efforts are minimal compared to the benefits we can reap in a short time: it will maximize the efficiency of health-care systems and meaningfully contribute to better health for all.”

Implementation toolkit for accessible telehealth services

WHO-ITU Global standard for accessibility of telehealth services

Global report on health equity for persons with disabilities

More on WHO’s work on disability

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Medical certificate of cause of death (MCCD): guidance for medical practitioners

Guidance for medical practitioners completing a medical certificate of cause of death in England and Wales.

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Guidance for medical practitioners completing medical certificates of cause of death in england and wales.

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Nearly 1 Million More Medicare Beneficiaries May Be Affected in Year-Old Data Breach

How to protect yourself if medicare says your personal information has been exposed.

Kimberly Lankford,

In this story

New names, old breach • Review catches problems • Protect your information

The Centers for Medicare & Medicaid Services (CMS) is notifying almost a million beneficiaries whose personal information may have been compromised in a contractor’s data breach last year.

The contractor, Madison-based Wisconsin Physicians Service Insurance Corp., processes Medicare claims for CMS in six states: Illinois, Iowa, Kansas, Michigan, Missouri and Nebraska. But beneficiaries elsewhere could be affected if they used providers in those states. The notification to 946,801 Medicare beneficiaries comes more than a year after a security vulnerability was discovered in file-transfer software called MOVEit .

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Wisconsin Physicians Service collects information such as Medicare and Social Security numbers to manage Medicare claims and audit health care providers. The Medicare beneficiaries’ personally identifiable information was exposed between May 27 and May 31, 2023, but the company patched its MOVEit software and initially thought none of its records had been part of the data breach.

New review unearthed previous copying of records

In May of this year, Wisconsin Physicians Service again reviewed its MOVEit file transfer system with help from a cybersecurity firm, discovering that files had been copied before the patch was put in place. Portions of the files had no personal information, but other parts evaluated July 8 were determined to include information valuable to hackers:

• Hospital account number
• Medicare or health insurance claim number
• Social Security number or taxpayer identification number

In August 2023, CMS said the MOVEit data breach had affected 612,000 Medicare beneficiaries. Other commercial and government customers worldwide also use the file transfer application.

“The Centers for Medicare & Medicaid Services have issued … multiple notices in July 2023 related to third-party administrators who were users of the MOVEit transfer software,” says James E. Lee, chief victims officer for the San Diego-based Identity Theft Resource Center. “This is the first breach notice related to Wisconsin Physicians Service Insurance Corp., and it too is linked to the MOVEit breach from last year.”

CMS and Wisconsin Physicians Service say they are not aware of reports of identity fraud or improper use of the personal information as a direct result of the breach but are mailing notifications to the Medicare beneficiaries telling them of steps they can take to protect their financial health .

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How to protect your personal information

You can take steps to help monitor your Medicare and credit record and further protect your privacy:

1. Enroll in free credit monitoring. Wisconsin Physicians Service is offering 12 months of free credit monitoring and other services from Experian to people affected. The notice includes steps for enrolling; you do not need to provide your credit card number to sign up.

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2. Order a free credit report. Under federal law, you can order one free credit report  every 12 months from each of the three major credit agencies — Equifax, Experian and TransUnion — or by calling 877-322-8228. But you can check those reports every week online . Review the reports for suspicious activity and check them periodically.

Report incorrect information to the credit reporting company. If you believe your information is being misused, contact local law enforcement and file a complaint to the Federal Trade Commission .

3. Consider freezing your credit. “Credit monitoring is helpful, but it only tells you what has happened,” Lee says. “It does not stop new credit accounts from being opened in your name.” By freezing your credit , you limit access to your credit history and make it more difficult for identity thieves to open new accounts in your name.

4. Use your current Medicare card for now. If your Medicare number was affected, CMS will mail a new Medicare card to you with a new number in the next few weeks. In the meantime, you can use your current card. When the new card arrives, destroy your old card and let your doctors and other providers know about the new card number.

5. Review your Medicare claims notices. “In health care breaches, it’s important that victims review their benefit statements to determine if anyone has accessed medical services under their name,” Lee says. You receive a Medicare Summary Notice every three months reporting the Medicare claims made in your name.

You can review Medicare claims more quickly using your online Medicare account . Contact the doctor’s office about any problems and report claims you didn’t make to Medicare at 800-633-4227. You can also contact the Senior Medicare Patrol , which receives grants from the federal government and has branches in each state to help detect and report Medicare fraud. Find contact information for your state on the SMP resource center website or by calling 877-808-2468.

Kimberly Lankford is a contributing writer who covers Medicare and personal finance. She wrote about insurance, Medicare, retirement and taxes for more than 20 years at  Kiplinger’s Personal Finance  and has written for  The Washington Post  and  Boston Globe . She received the personal finance Best in Business award from the Society of American Business Editors and Writers and the New York State Society of CPAs’ excellence in financial journalism award for her guide to Medicare.

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Regulatory Proposal PRO2024-04, Consultation on guidance for registrants and data holders for use or reliance on test data considered in support of re-evaluation and special review decisions

Health Canada – Pest Management Regulatory Agency 10 September 2024 ISSN: 1925-122X (PDF version) Catalogue number: H113-8/2024-4E-PDF ( PDF version - 398 KB )

Table of contents

1.0 consultation foreword, 2.0 introduction, 3.1 use or reliance on on-hand test data relevant to the equivalent active ingredient under re-evaluation or special review, 3.2 use or reliance on on-hand test data relevant to a non-equivalent active ingredient, 3.3 use or reliance on test data that is called in under subsections 16(3), 18(1), 19(1) of the pest control products act, 4.1 availability of lists of test data for which compensation may be payable for re-evaluations and special reviews, 4.2 test data requests communicated in writing, 4.3 eligibility of test data where the compensable protection period ended after the publication of the re-evaluation or special review decisions, 4.4 participating registrants during re-evaluations or special reviews, 4.5 compensation requirements if products have since been cancelled, 4.6 data holders' and other registrants' review of the initial list of test data for which compensation may be payable, 4.7 eligibility criteria for test data for which compensation may be payable for re-evaluations and special reviews, 4.8 re-evaluation or special review decisions with full cancellation, 4.9 re-evaluation or special review decisions with cancellation of some uses, 4.10 foreign reviews or foreign regulatory decisions, 5.0 negotiation and binding arbitration, 6.0 letter of access and renewal of registration, 7.0 process for determining the list of test data for which compensation may be payable, 8.0 requests for discontinuation of product registration once the list of test data for which compensation may be payable has been made available to registrants and data holders, appendix i eligibility criteria for test data for which compensation may be payable, appendix ii letter of access, appendix iii process for determining the list of test data for which compensation may be payable, appendix iv list of test data for which compensation may be payable, appendix v list of identified re-evaluation and special review decisions published before 4 december 2023, where the pmra may make available lists of test data for which compensation may be payable.

This document is open for public consultation for 60 days from the publication date. Health Canada's Pest Management Regulatory Agency (PMRA) will consider all comments received before finalizing the guidance document.

The final guidance would be used in conjunction with the Pest Control Products Act and the Pest Control Products Regulations ( Canada Gazette, Part II publication SOR/2010-119 on 23 June 2010) and also as amended on 21 September 2017 with the Canada Gazette, Part II , publication SOR/2017-169 (2017 Amendments), and the Consultation on the Proposed Agreement for Test Data Compensation under Section 66 of the Pest Control Products Act for Re-evaluation and Special Review Decisions Published before 4 December 2023 . Footnote 1

Please forward your comments to email: [email protected] . Questions or comments can also be directed to the Pest Management Information Service.

Comments should include:

• Title of this consultation document;
• Your full name and organization;
• Your phone number; and
• Your complete mailing address or email address.

On 3 June 2010, the data compensation provisions in the Pest Control Products Regulations came into force (2010 Regulations) Footnote 2 . This established a regulatory framework by which an applicant may use or rely on test data provided by a registrant in the context of an application to register a pest control product or to amend a registration. These provisions also applied, with any necessary modifications, to a registrant who wished to use or rely on test data of a data holder for the purpose of re-evaluations and special reviews.

Guidance to implement the data compensation provisions in the context of an application to register a pest control product or to amend a registration was published in 2010, Footnote 3 and 2014; Footnote 4 but these guidance documents did not address the use of or reliance on data holders' test data by registrants for re-evaluations or special reviews.

On 7 June 2023, amendments to the data compensation provisions of the Pest Control Products Regulations were published in the Canada Gazette, Part II , and on 4 December 2023 they came into force (SOR/2023-104). Footnote 5

These amendments are intended to provide clarity regarding data compensation for re-evaluations and special reviews, such as which party can trigger the negotiation and binding arbitration process; when and how to trigger such processes; and when the lists of test data for which compensation may be payable will be made available for re-evaluation and special review decisions published after 4 December 2023. To support the implementation of the amendments related to data compensation for re-evaluations and special reviews, the PMRA published a guidance document Footnote 6 as well as a section 66 Agreement Footnote 7 for re-evaluations and special reviews.

The amendments also aim to clarify the data compensation requirements for applications to register and to amend a registration and to establish consistency with the new data compensation provisions for re-evaluations and special reviews. Some of these amendments address data compensation for use or reliance on foreign test data and on test data for non-equivalent active ingredients subject to exclusive rights. The PMRA also published a section 66 Agreement for pest control product applications to support these amendments. Footnote 8

As the amended data compensation provisions only apply to re-evaluation and special review decisions published after 4 December 2023, the former regulations (in other words, the 2010 Regulations) continue to apply to re-evaluation and special review decisions published prior to that date. This proposed guidance supports the interpretation of the former data compensation provisions, and is to be used in conjunction with the Pest Control Products Act , the 2010 Regulations, and the draft Agreement for Test Data Compensation under Section 66 of the Pest Control Products Act for Re-evaluation and Special Review Decisions Published before 4 December 2023 Footnote 9 (section 66 Agreement), on which consultations are also being conducted.

For the purposes of this draft guidance document, the term "registrant" applies to the party seeking access to data. The term "data holder" refers to a registrant to whom compensation may be payable in respect of test data.

3.0 Use or reliance on data holder's test data for re-evaluations and special reviews

The Pest Control Products Act and the Regulations set out a regulatory process for data compensation for pest control products. For the purpose of re-evaluations and special reviews, a data holder's test data can be used or relied on by other registrants, as per Pest Control Products Act subsections 16(5) and (5.1) for re-evaluations, and subsections 18(3) and (3.1) for special reviews. As per section 17.8 of the 2010 Regulations, the PMRA will make available to registrants and data holders the list of test data considered by the Minister in support of the final re-evaluation or special review decision for which they will need to enter into an agreement regarding compensation that may be payable.

During a re-evaluation or special review, the PMRA considers relevant test data and other available information from pest control product registrants, published and unpublished scientific reports, reviews, and regulatory decision documents from other regulatory agencies. Here, only relevant test data that is called in and considered by the PMRA for the first time in support of a final re-evaluation or special review decision may be eligible for compensation. The PMRA's re-evaluations and special reviews may consider "on-hand" (in other words, previously submitted) test data relevant to the pest control product that is under review. If this "on-hand" test data is relevant to the equivalent active ingredient that is subject to the re-evaluation or special review, it will not be considered in the data compensation assessments as it is not eligible for compensation for the purposes of the re-evaluation or special review.

During a re-evaluation or special review, the PMRA considers all relevant data, including test data on-hand relevant to non-equivalent active ingredients. In other words, the PMRA may consider test data relevant to an active ingredient that is not equivalent to the active ingredient contained in the pest control product that is subject to a particular re-evaluation or special review. If this test data (in other words, on-hand test data relevant to a non-equivalent active ingredient) was considered in a final re-evaluation or special review decision published after 21 September 2017 and was within the compensable period when that re-evaluation or special review decision was made, then as per the 2010 Regulations, as amended on 21 September 2017, compensation may be payable to the data holder for use or reliance on this test data by other registrants. This is being implemented further to Canada's obligations under the Canada-European Union Comprehensive Economic and Trade Agreement (CETA). Footnote 10

Under subsection of 17.1 of the 2010 Regulations, test data submitted pursuant to notices delivered to a registrant under relevant subsections 16(3), 18(1) or 19(1) of the Pest Control Products Act during re-evaluations or special reviews are eligible for compensation if they are considered by the Minister in support of the re-evaluation or special review decisions. The PMRA may have issued notices under those provisions to registrants for information (in other words, scientific or technical test data) that were considered necessary to conduct the re-evaluation or special review.

The PMRA considers all relevant test data either on-hand at the PMRA or called-in from data holders in the context of a particular re-evaluation or special review. However, only test data that is called in, as well as on-hand test data relevant to active ingredients that is not equivalent to the active ingredient that is under re-evaluation or special review may be eligible for compensation; for the latter (i.e., the on-hand test data), compensability will be assessed only for decisions published on or after September 2017.

4.0 General information and approach

In accordance with the 2010 Regulations, the PMRA will establish lists of test data for which compensation may be payable for re-evaluations and special reviews that were initiated since June 28, 2006 (the coming into force date of the Pest Control Products Act , 2002), and for which a data call-in (DCI) notice was issued under subsections 16(3) or 18(1) or paragraph 19(1)(a) of the Pest Control Products Act after 3 June 2010 (the coming into force date of the data compensation provisions in the Pest Control Product Regulations). The PMRA is analyzing the decisions with respect to re-evaluations and special reviews published before 4 December 2023, to identify the decisions for which the establishment of lists of compensable test data is required (See Appendix V ). PMRA will establish such lists in the following order:

• Re-evaluation and special review decisions for active ingredients that have ongoing applications to register generic technical grade active ingredient products seeking to use or rely on data holders' test data.
• Re-evaluation and special review decisions for active ingredients that had recent data compensation assessments completed as a result of a product application.
• The remaining decisions in chronological order starting with the oldest first.

The PMRA requested the submission of test data for re-evaluations and special reviews in writing, including via email correspondence or consultation documents. If such test data were used in support of final decisions, they may be eligible for compensation as set out in Section 4.1 .

Test data may be eligible for compensation if the compensable protection period had not expired by the date of the publication of the final re-evaluation or special review decision under subsection 28(5) of the Pest Control Products Act .

All technical grade active ingredient registrants who maintained the registrations of their technical grade active ingredient products since the date of the publication of the re-evaluation or special review decision are subject to the data compensation requirements under the 2010 Regulations. The negotiation and, if necessary, binding arbitration provisions apply to determine whether any compensation is payable for reliance on data holders' test data.

This guidance does not apply to pest control products that were registered after a re-evaluation or special review of the active ingredient contained in that pest control product. Registrations of those products were subject to the application process that took into consideration the test data used in the re-evaluation or special review.

Some registrations of technical grade active ingredients have been cancelled since the date of the publication of the associated re-evaluation or special review decision. In this case, the former registrants of these cancelled products are not required to pay compensation or to participate in the negotiation/arbitration process for access to test data considered in support of the applicable re-evaluations or special reviews.

An initial list of test data for which compensation may be payable will be sent to the data holders and other registrants whose products are subject to the re-evaluation or special review decision. Data holders and other registrants will have 30 days to provide comments to the PMRA on the scope of the list of test data. Following that, the PMRA will consider all input received and proceed to finalize the list of test data for which compensation may be payable. This list will be made available to all parties referenced above to allow them to initiate negotiations.

Eligibility criteria for test data that was considered in support of re-evaluation and special review decisions and for which compensation may be payable are outlined in Appendix I of this document.

Registrants are not required to pay compensation if the pest control product registrations subject to the re-evaluation or special review were cancelled as a result of the re-evaluation or special review decision.

A re-evaluation or special review decision may conclude that the risks and the value of a pest control product are acceptable with the amendment of the registration (e.g., to establish additional risk mitigation measures). In the context of a re-evaluation or special review, studies (for example, toxicology or dietary) considered in support of a decision generally apply to all products under review and support the overall decision, including the cancellation of certain uses, or the implementation of additional mitigation measures. Registrants whose products are subject to the re-evaluation or special review decision are required to compensate for the use of or reliance on a data holder's test data that supports a re-evaluation or special review decision, including a decision resulting in the cancellation of certain uses.

The PMRA often considers publicly available reviews or regulatory decision documents from other regulatory bodies, such as the United States Environmental Protection Agency (USEPA), European Food Safety Authority (EFSA), or Australian Pesticide and Veterinary Medicine Authority (APVMA), in support of re-evaluation or special review decisions. Foreign reviews or foreign regulatory decision documents considered in support of a re-evaluation or special review decision are not compensable.

However, the PMRA may have reviewed certain underlying studies referenced in foreign reviews or foreign regulatory decision documents to confirm the interpretation or conclusion regarding specific matters addressed in these documents. In this situation, the test data from those underlying foreign studies would have been called in by the Minister under subsections 16(3) or 18(1), or paragraph 19(1)(a) of the Pest Control Products Act. If the studies were used to support a final re-evaluation or special review decision, compensation may be payable for the use of or reliance on those called-in underlying foreign studies.

Under section 66 of the Pest Control Products Act , the Minister is required to determine the terms and conditions of agreements entered into by registrants and data holders for the purposes of determining compensation payable for the use or reliance by registrants on data holders' test data (section 66 Agreement). In accordance with the 2010 Regulations, once a final list of test data for which compensation may be payable is established for a prior re-evaluation or special review, the PMRA will provide the list to the registrant and data holder. Either the registrant wishing to use or rely on the data holder's data or the data holder themselves may deliver the proposed section 66 Agreement to the other party that specifies the test data for which compensation may be payable. On delivery of the proposed section 66 Agreement by either party, the parties must enter into the agreement and begin to negotiate the amount of compensation payable to the data holder.

Under the Regulations, the negotiation period will run for 120 days upon delivery of the proposed agreement, but can be extended upon written agreement between the parties. At the end of the negotiation period, if no settlement is reached, either party may trigger binding arbitration by delivering a written notice to the other party. The arbitrator must make an arbitral award within 120 days after the day on which the notice was delivered unless the parties agree to extend that period and provide written notice to the arbitrator or the arbitrator provides written notice of an extension to the parties.

Arbitration is binding on parties and generally an award will be rendered by the Arbitral Tribunal before the end of the proceedings. The award will set out the compensation payable for use or reliance on the data holder's test data and any costs payable by either party to the arbitration.

Once a negotiated settlement has been reached or an arbitral award has been issued, the data holder must provide the other registrant with a letter of access (LOA) allowing the registrants to use or rely on the list of test data for which compensation may be payable in Appendix A of the section 66 Agreement as per subsection 17.94(1) of the 2010 Regulations.

If the data holder fails to provide the LOA within the period specified in the negotiated settlement or arbitral award, the registrant may use or rely on the test data without having to continue to comply with the settlement or award as per subsection 17.94(2) of the 2010 Regulations.

At the next registration renewal as per subsection 16(2) of the Regulations following the conclusion of the negotiation or arbitration period, registrants using or relying on the data holder's test data will be required in their renewal applications to provide an LOA, or relevant documents indicating that parties are still in negotiation or arbitration, or that though a negotiated settlement has been reached or an arbitral award issued, the data holder has not provided the registrant with an LOA.

LOAs are to be signed using the attached template in Appendix II .

The process for determining the list of test data for which compensation may be payable is in Appendix III .

There may be circumstances where a registrant is subject to a re-evaluation or special review decision published prior to 4 December 2023, and they notify the PMRA, pursuant to subsection 22(1) of the Pest Control Products Act , that they seek to discontinue their product registrations after the PMRA has made available a list of test data for which compensation may be payable. The PMRA will cancel the registration of their products in accordance with subsection 22(3) of the Pest Control Products Act . The PMRA may allow for a phase-out period, with timelines consistent with the Regulatory Directive DIR2018-01 , Policy on Cancellations and Amendments Following Re-evaluation and Special Review .

When a section 66 Agreement has been entered into on delivery, by either party, the terms and conditions of that agreement apply. If a registrant requests to discontinue their product's registration and the Minister cancels their registration under subsection 22(3) of the Pest Control Products Act , the terms of the section 66 agreement entered into continue to apply to that party.

Registrants not wanting to be subject to the terms and conditions of the section 66 Agreement are encouraged to have their registrations cancelled prior to the list of test data for which compensation may be payable being made available to registrants and data holders.

Pursuant to subsection 17.7(2) of the 2010 Regulations, the following test data are eligible for compensation if considered by the Minister in support of a re-evaluation or special review decision initiated since 28 June 2006:

• Test data that is relevant to an active ingredient that is not equivalent to the active ingredient under the re-evaluation or special review, if the Minister is satisfied that such information is necessary for the re-evaluation or special review decision published on or after 21 September 2017, and
• Test data provided in response to data call-in (DCI) notices issued on or after 3 June 2010 under subsections 16(3), 18(1), or paragraph 19(1)(a) of the Pest Control Products Act, for re-evaluations or special reviews .

Test data and other information that is not eligible for compensation for re-evaluations and special reviews include, but are not limited to, the following:

• Test data where the compensable period or exclusive use period expired prior to the publication date of the final re-evaluation or special review decision.
• Summaries of information (including executive summaries).
• Test data waivers /scientific
• Test data in the public domain (for example, data published in the open literature, published foreign reviews or foreign regulatory decision documents).
• Test data in a scientific or technical study that is fully funded by a government or one of its institutions
• Test data that the PMRA deemed to be invalid for regulatory
• Test data that is on hand and that is relevant to an active ingredient equivalent to the active ingredient under the re-evaluation or special review.
• Test data submitted
• Test data that was received in response to a DCI, issued before 3 June 2010 under subsections 16(3), or 18(1), and or paragraph 19(1)(a) of the Pest Control Products Act.
• Test data that was received in response to a DCI issued after 3 June 2010 under subsections 16(3), or 18(1), and paragraph 19(1)(a) of the Pest Control Products Act for a re-evaluation or special review initiated before 28 June 2006.
• Test data requested under section 12 of the Pest Control Products Act.
• Test data received with an incident report submitted under section 13 of the Pest Control Products Act .

[Data Holder Company Letterhead]

Director General, Registration Directorate Pest Management Regulatory Agency Health Canada

Subject: Letter of access to [Name of Registrant]

This is to inform you that [Name of Data Holder] is granting to [Name of Registrant] the right to use or rely on [Name of Data Holder]'s test data identified in the Pest Management Regulatory Agency's letter of [Date], regarding the re-evaluation or special review decision (RVD20XX-XXXX or SRD20XX-XXXX).

Yours truly,

[Data Holder's signature]

[Printed signatory name and contact information]

Assessments of test data for which compensation may be payable will be carried out for the purposes of subsections 16(5) and (5.1), and 18(3) and (3.1), of the Pest Control Products Act and the Pest Control Products Regulations in other words, the 2010 Regulations and the 2017 Amendments). The PMRA will follow the eligibility criteria outlined in Appendix I in assessing the test data for which compensation may be payable. The process for determining the list is set out below.

Step 1 – PMRA establishes initial list of test data for which compensation may be payable

An initial list of test data will be established by considering the eligibility criteria outlined in Appendix 1 and cross-referencing the reference lists in the relevant published re-evaluation or special review documents.

Step 2 – Data holders and other registrants review the initial list of test data for which compensation may be payable

The initial lists of test data for which compensation may be payable will be presented as per the template in Appendix IV , for the active ingredients listed in Appendix V . Data holders and other registrants will be provided with a 30-day period to review and provide written comments to the initial list.

Any written comments must demonstrate how the test data identified meet/or do not meet the criteria for compensation set out in Appendix I .

This step is an opportunity for data holders and other registrants to provide input on whether the initial list of test data for which compensation may be payable was established as per the eligibility criteria outlined in Appendix I . It is not an opportunity to question why certain test data was considered or not in support of a decision by the PMRA. Other opportunities were available as part of the re-evaluation and special review processes where data holders and other registrants could comment on the studies considered in support of decisions made prior to 4 December 2023, by the PMRA.

Step 3 – PMRA makes available final list of test data for which compensation may be payable

The PMRA will consider the written comments provided by data holders and other registrants and will finalize the list of test data for which compensation may be payable. The initial list of test data may be revised if deemed necessary. A final list of test data for which compensation may be payable containing the eligible test data considered in support of the Minister's re-evaluation or special review decision will be made available to relevant registrants and data holders using the format in Appendix IV .

The initial list of test data for which compensation may be payable for the re-evaluation or special review of an active ingredient will be presented in the following format:

• Data code (DACO)
• Study title
• Report number
• Report date
• Received date
• PMRA assessment

PMRA, "Consultation on Proposed Agreement for Data Compensation under Section 66 of the Pest Control Products Act for Re-evaluation and Special Review Decisions Published before 4 December 2023," 2024, https://www.canada.ca/en/health-canada/services/consumer-product-safety/pesticides-pest-management/public/consultations.html.

Return to footnote 1 referrer

See SOR/2010-119: https://www.gazette.gc.ca/rp-pr/p2/2010/2010-06-23/pdf/g2-14413.pdf.

Return to footnote 2 referrer

PMRA, "Regulatory Directive DIR2010-04: Guidelines for Reliance on Proprietary Data Under the Pest Control Products Regulations," 2010, https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/policies-guidelines/regulatory-directive/2010/dir2010-04-guidelines-reliance-proprietary-data-under-pest-control-products-regulations.html.

Return to footnote 3 referrer

PMRA Memo to Registrants, Data Protection Submission Review Process, https://www.canada.ca/en/health-canada/services/consumer-product-safety/pesticides-pest-management/registrants-applicants/product-application/memo/data-protection-submission-review-process.html.

Return to footnote 4 referrer

Regulations Amending the Pest Control Products Regulations (Exclusive Rights and Compensable Data): SOR/2023-104 (Canada Gazette, Part II, Volume 157, Number 12, online: https://www.gazette.gc.ca/rp-pr/p2/2023/2023-06-07/pdf/g2-15712.pdf).

Return to footnote 5 referrer

PMRA Guidance Document, "Guidance for Registrants and Data Holders for Use or Reliance on Test Data Considered In Support Of Re-Evaluation And Special Review Decisions, 2023, https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/policies-guidelines/guidance-registrants-data-holders-use-reliance-test-data-considered-support-reevaluation-special-review-decisions.html.

Return to footnote 6 referrer

PMRA, "Agreement for test data compensation under section 66 of the Pest Control Products Act for re-evaluations and special reviews," 2023, https://www.canada.ca/en/health-canada/services/consumer-product-safety/pesticides-pest-management/public/protecting-your-health-environment/pest-control-products-acts-and-regulations-en/agreement-test-data-compensation-section66-pest-control-products-act-reevaluations-special-reviews.html.

Return to footnote 7 referrer

PMRA, "Agreement for test data compensation under section 66 of the Pest Control Products Act for pest control product applications," 2023 https://www.canada.ca/en/health-canada/services/consumer-product-safety/pesticides-pest-management/public/protecting-your-health-environment/pest-control-products-acts-and-regulations-en/agreement-test-data-compensation-section66-pest-control-products-act-product-applications.html.

Return to footnote 8 referrer

Return to footnote 9 referrer

For additional context, prior amendments related to CETA include: 2017 amendments to the Pest Control Products Act through Bill C-30, "Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act S.C. 2017, c. 6", https://laws-lois.justice.gc.ca/eng/acts/C-4.8/index.html, and "Regulations Amending the Pest Control Products Regulations (Test Data Protection)", which can be found here: https://www.gazette.gc.ca/rp-pr/p2/2017/2017-09-07-x1/pdf/g2-151x1.pdf#page=67.

Return to footnote 10 referrer

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