Registration of in under the Joint Review Program

Lilian de Luna, Ph.D. Pest Management Regulatory Agency,

Workshop on Risk Assessment, Risk Management and Risk Communication, World Trade Organization, 13 July 2021 Regulation in Canada • Pesticides are regulated at the federal, provincial and municipal levels • Authority to regulate pesticides – Products Act • Health Canada’s Pest Management Regulatory Agency tasked with regulation of pesticides at the federal level • Pre-market assessment as well as Post-market assessment (re-evaluation)

2 What is a Joint Review? • A formal process where the review of a pesticide dossier is shared by two or more countries – Timelines are negotiated in advance – Workload (on a science discipline basis) is divided among the participating regulatory authorities – Data evaluations are exchanged and peer-reviewed by all participating regulatory authorities, and are used as the basis for each country’s risk assessment and regulatory decision.

3 Development of Joint Reviews in Canada • NAFTA Joint Reviews (since 1996) • Demonstrated that joint reviews were feasible and that there were many benefits • Paved the way for global joint reviews

• Global Joint Reviews – In 2007, the first “global” joint review submission was received (chlorantraniliprole), involving Canada, the United States, Ireland, the UK, Australia, and New Zealand. – Joint Reviews have been the standard way of doing business for new conventional agricultural chemicals (US, Canada, Australia, EU). • Expansion of participating countries and pesticide companies • Inclusion of European Food Safety Authority (EFSA) in global joint reviews

4 Eligibility Criteria for Joint Reviews • Must be a new active ingredient in all participating jurisdictions.

• The active ingredient and/or associated end-use product(s) is to be marketed in a significant number of countries, or it is anticipated that commodities treated with the active ingredient will be exported widely.

• The timeline for dossier submission and the marketing of the active ingredient and/or end-use product(s) must be similar in all countries.

• The proposed uses are applicable for the countries/regions intended for marketing

• Ideally, at least one end-use product should be common to all participating countries

• If the end-use product is a co-formulation with other active ingredients, the other active ingredients should: – already be registered in the other countries – already be registered for the proposed use pattern

5 Joint Review Process • Pre-submission Consultation • Completeness Check/Screening (3 months) • Primary Review/Study Evaluation (7 months) • Secondary Review (4 months) • Independent Country Specific Risk Assessment (4 months) • Independent decision-making

6 Joint Review Process: Initiation

• Requests for a joint review by industry • Pre-submission Consultation – Mandatory / critical for success. The company should start the pre- submission consultation process at least 2 years before the target date of dossier submission for new active ingredients

– Part of the pre-submission consultation should include: • reasons why the proposed product(s) is a suitable candidate for the joint review process (i.e., meets criteria) • benefits accrued from undertaking a joint review for the active ingredient and/or end-use product(s). • anticipated date of dossier submission for the joint review.

– A technical pre-submission consultation addresses the science and format issues 7 Joint Review Process: Planning • Project Plan is developed and approved

• Administrative Lead: – One of the regulatory authorities is designated as project lead (coordination/administrative role) – primary and secondary contacts identified for each regulatory authority as well as the company to facilitate communication.

• Work split – division of the review work is confirmed

• Timelines (negotiated) – key milestones and dates – deliverables 8 Joint Review Process: Review • Review – Completeness Check • Preliminary review of data package and confirmation of individual study review responsibilities – Primary review • Detailed review of data/information provided (establish use pattern, toxicology endpoints, etc.) – Secondary review • Secondary review agencies peer review primary reviews and discuss issues/agreements/disagreements • Communication – Teleconferences are arranged throughout the process to discuss issues and track progress (applicant involved as required) – Primary reviews and peer review comments are exchanged by email

9 Joint Review Process: Review (continued) • Independent country-specific risk assessment (as per each country’s legislative/policy requirements) – Partner agencies are informed of results of country specific risk assessment • Independent decision making

10 Benefits of Joint Reviews • Increases the efficiency of the registration process, which allows sharing of assessment work on often large and complex scientific dossiers.

• Facilitates the simultaneous evaluation of new pesticides in several jurisdictions, while meeting country-specific regulatory requirements.

• Provides Canadian growers with same time access to pest control products as other countries (e.g., the United States).

• Strengthens the regulatory process (e.g. peer-review process using the best available science, harmonizing science where possible)

• The Global Joint Review process has resulted in harmonized MRLs for most crops and thereby aid in reducing agricultural trade barriers.

11 Challenges • Communication

• Different legislation and policies in the various countries can present challenges throughout the joint review.

• Size and complexity of dossier can present challenges for reviewers and affect timelines.

12 Moving Froward • Improving communication

• Streamlining and introducing flexibility to the joint review process

13 Thank you

Merci

https://www.canada.ca/en/health-canada/services/consumer- product-safety/pesticides-pest-management.html

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