Comprehensive Economic and Trade Agreement Regulatory Cooperation Forum – Work plan
The Comprehensive Economic and Trade Agreement (CETA) Regulatory Cooperation Forum (RCF) work plan is a living document and will be updated on an ongoing basis as regulatory cooperation opportunities arise, and following each RCF meeting.
On September 21, 2017, the Canada-EU CETA entered into force provisionally. Chapter 21 lays out the framework for regulatory cooperation activities, including the establishment of the RCF. The chapter builds on and replaces an existing agreement between the EU and Canada on regulatory cooperation ('Framework on Regulatory Co-operation and Transparency between the Government of Canada and the European Commission, done at Brussels on 21 December 2004’).
The role of the RCF is to facilitate and promote regulatory cooperation between the Parties. RCF will perform the following functions:
- Provide a forum to discuss regulatory policy issues of mutual interest that the Parties have identified through, among others, consultations conducted in accordance with Article 21.8.
- Assist individual regulators to identify potential partners for cooperation activities and provide them with appropriate tools for that purpose, such as model confidentiality agreements.
- Review regulatory initiatives, whether in progress or anticipated, that a Party considers may provide potential for cooperation. The reviews, which will be carried out in consultation with regulatory departments and agencies, should support the implementation of this Chapter.
- Encourage the development of bilateral cooperation activities in accordance with Article 21.4 and, on the basis of information obtained from regulatory departments and agencies, review the progress, achievements and best practices of regulatory cooperation initiatives in specific sectors.
On the EU side the work is led jointly by DG GROW and DG TRADE and on the Canadian side jointly by the Treasury Board of Canada Secretariat and Global Affairs Canada.
- Outi Slotboom (DG GROW, European Commission)
- Rupert Schlegelmilch (DG TRADE, European Commission)
- James Van Raalte (Treasury Board of Canada Secretariat)
- Doug Forsyth (Global Affairs Canada)
- Report annually to the CETA Joint Committee on the implementation of CETA Chapter 21;
- Convene annually unless the parties decide otherwise;
- Provide an annual forum, unless the Parties decide otherwise, for regulators to engage in topic-specific discussions and update the RCF co-chairs on the status of their cooperation activities;
- Debrief stakeholders following the annual RCF meetings, providing opportunities for stakeholders who cannot be physically present to engage virtually;
- As required, provide ongoing support and guidance to facilitate regulator-to-regulator discussions on existing and potential regulatory cooperation issues; and
- Post online RCF agendas, work plans and reports.
To inform their regulatory cooperation activities, including the exchanges of regulators at RCF meetings, both Parties have carried out consultations in line with the Article 21.8 of CETA, in order to collect views of European and Canadian stakeholders for potential topics where EU and Canadian regulators can meaningfully cooperate.
- Stakeholder submissions to the Commission have been made public on the Commission’s website.
- Stakeholder submission to Canada have been published on the Canada.ca website.
Each Party may choose to conduct additional stakeholder consultations to inform their issues and sectors of interest under the RCF.
Work plan development
Informed by the input Canada and the Commission received through their consultations, the Parties have exchanged proposals that outline the issues, sectors and regulatory areas that are of interest to them. Through internal analysis and discussions with their respective regulators, as well as through dialogues with one another, the Parties are working to identify those issues that are of mutual interest. While these dialogues and exchanges continue, both Parties have agreed that work on the exchange of information on the safety of consumer products as defined in the Article 21.7 of CETA should start expeditiously
As the Parties reach agreement on areas that are of mutual interest, they will work with regulators to add these items to a table of cooperation areas (Annex A), which includes actions and timelines.
Overview of CETA RCF Regulatory Cooperation Areas
Sector: Consumer product safety
Canadian department: Health Canada
European department: European Commission, Directorate-General for Justice and Consumers (DG JUST)
Regulatory cooperation statement: The safety of consumer products sold on their national markets is a major concern for regulators around the world. The increased globalization of markets and supply chains, the rise of online/cross-border shopping, and the increasing number of new products reaching markets have made physical borders non-existent. The same consumer products or types of products appear in similar markets, which means that authorities in the EU and in Canada often face similar product safety challenges. In this context, it is imperative that the Government of Canada and the European Union regulators cooperate to efficiently identify and take appropriate action on potentially dangerous consumer products.
Initiative: Regular exchange of information between the EU RAPEX alert system and Canada’s RADAR consumer product incident reporting system (CETA Article 21.7(4)-(6)); ad hoc information exchange and cooperation on other aspects of non-food product safety (CETA Article 21.7(3)).
- Canadian and European regulators have timely and detailed consumer product safety information coming from each other, allowing for better informed decisions to fulfill their mandate of improving the health and safety of their citizens in relation to consumer products:
- Easier access to important information related to potentially dangerous products in each jurisdiction
- Better capacity for coordination of communication, market surveillance and enforcement activities in both jurisdictions
- Improved collaboration between regulators of both jurisdictions
|CETA Article 21.7(4)-(6)|
|Regular exchange of information between EU RAPEX and Canada's RADAR systems||Q1-Q4 2021||Ongoing||Regular exchange of information is up and running, as per the administrative agreement between DG JUST and Health Canada|
|CETA Article 21.7(3)|
|Coordinated market surveillance activity||Q1-Q4 2020, Q1-Q2 2021||Completed||The first coordinated market surveillance initiative addressed heavy metals in children’s jewellery. Participants exchanged information on their sampling and testing methodologies, discussed communication messages and exchanged test results. The collaboration allowed to identify unsafe products in both marketplaces, which led to concrete measures. Participants look forward to potential further cooperation in other product categories.|
|Coordinated awareness-raising campaign||Q2 Q4 2021||Completed (planning future outreach)||Participants continue to collaborate on joint communication initiatives. The third joint outreach initiative (on children’s water safety) is currently being prepared for the summer of 2021 while a fourth campaign (on toy safety) is planned for end 2021.|
|Bilateral tele-conferences||Q1-Q4 2021||Ongoing||Participants are holding regular teleconferences at working level to discuss consumer product safety issues (including emerging issues such as products related to COVID-19) and to identify possible areas of cooperation to improve the safety of consumer products in the markets within their respective jurisdictions.|
Sector: “Cosmetic-Like” Drug Products
Canadian department: Health Canada
European department: European Commission, Directorate-General Internal Market, Industry, Entrepreneurship and SMEs (DG GROW)
Regulatory cooperation statement: Canada is seeking to increase regulatory harmonization with the EU regarding specific “cosmetic-like” products.
Initiative: Eliminate Canada’s quarantine and confirmatory re-testing requirements for low-risk “cosmetic-like” drug products imported from the E.U.
Eliminating Canada’s quarantine and confirmatory re-testing for certain types of low-risk drug “cosmetic-like” products from the EU to reduce unnecessary regulatory differences and burden to industry.
Modernize Canada’s regulatory framework for self-care products (including cosmetics, natural health products and non-prescription drugs) by tailoring the level of oversight to their level of risk and allow for continued innovation in the field of health products, while reducing any unnecessary burden and duplicative red tape.
Health Canada is considering an expansion of the Pilot to include additional types of low-risk "cosmetic-like" OTC products fabricated in compliant EU facilities.
|Exemption from re-testing/quarantine of EU sunscreen products||Completed||Closed as of July 1, 2020||Given success, pilot project has been implemented through regulation.|
|Exemption from re-testing/quarantine of EU low risk cosmetic-like products, i.e. toothpastes and antidandruff shampoos||Targeting FY 2020 - 2021||With the coming into force of the regulatory amendments under the Canada-United States-Mexico Agreement, requirements for re-testing and quarantine of imported low-risk cosmetic-like products (including Anti-dandruff shampoos) from certain recognized countries and regions (including MRA partnersFootnote 1) has been removed.|
Based on the consultation toothpastes will be added to the list of products exempted from re-testing/quarantine.
Health Canada explored expanding the list of products through a consultation with external stakeholders.
The consultation was completed in October 2020. Feedback from the consultation was positive and there was an overall support for updating the list.
As a result of stakeholder feedback received during the consultation, Health Canada will be updating the list of products to reflect the changes proposed as part of the consultation. A full list will be shared once finalized.
Sector: Pharmaceutical Inspections
Canadian department: Health Canada
European Department: European Commission, Directorate-General Health and Food Safety (DG SANTE)
Regulatory cooperation statement: In October 2016, Canada and the EU signed the Comprehensive Economic and Trade Agreement (CETA) Protocol on the mutual recognition of the compliance and enforcement programme regarding good manufacturing practices for pharmaceutical product. In addition to allowing continued mutual recognition each other’s certificates of GMP compliance, the Protocol article 5(2) indicates that Canada and the EU may accept certificates of GMP compliance issued by an equivalent regulatory authority of the other Party with respect to a manufacturing facility outside the territory of the Parties.
These certificates are currently exchanged on a voluntary basis by Canadian and European Regulatory Authorities in situations deemed appropriate by the Parties.
There is an opportunity to officially recognize pharmaceutical inspections conducted in third countries and implement the exchange of certificates in order to further enhance cooperation and regulatory alignment between the EU and Canada.
Initiative: Expanding the existing approach of recognizing inspection results from the respective Parties to include inspections that are conducted in countries outside of the respective Parties’ jurisdictions (i.e. extra-jurisdictional inspections)
Desired outcome: Mutual recognition of inspection results would lead to more efficient and effective regulatory oversight and benefits trade between Canada and the EU without diminishing the high standards of safety and quality that exist in both jurisdictions. It would also reduce regulatory burden on industry and lead to better regulatory alignment among international regulatory partners.
|Activity 1 – Identification of possible differences between GMP inspections conducted outside of the territories of the Parties||Completed||A document identifying the differences between inspections conducted within the national territory and in third countries shows that the differences are similar for both parties. This document was tabled at the Joint Sectoral Group on Pharmaceuticals (JSG) of 21/11/2019, and following internal consultation by both parties, was considered finalised.||Once recognised, article 5(2) should then be applicable to third party inspections with respect to medicinal products or drugs of the operational scope of the Annex 1 of the CETA Protocol on GMPs for Pharmaceuticals.|
|Activity 2 – Conclusion of the comparative analysis||Completed||The document developed under Activity 1 was discussed by the Co-chairs at the Joint Sectoral Group on December 11, 2020 that concluded that Canada and the EU have similar approaches to inspections in third countries.||For medicinal products, or drugs covered by the operational scope of the Annex 1 of the CETA Protocol on Pharmaceuticals, the conclusion of the equivalence assessment of differences and similarities in the conduct of third party inspections (Activity 1) should take into account the recognition of the outcome of inspections in third countries by both Parties.|
|Activity 3 - Exchange of GMP information on inspections conducted outside of the territories of the Parties||Completed||EU and Canada regulators can recognize the results of inspections carried out by each party’s experts in third countries’ pharmaceutical facilities. This will help EU and Canadian authorities to better deploy scarce resources on health priorities and facilitate imports of medicinal products while maintaining high control standards.||The exchange of GMP certificates for extra jurisdictional inspections outcomes between EU and Canada was launched on April 1st, 2021 in Canada, and on April 15th, 2021 in the EU. The work plan is now completed.|
Sector: Animal Welfare
Canadian department: Agriculture and Agri-Food Canada
European department: European Commission, Directorate-General Health and Food Safety (DG SANTE) and Directorate-General Trade (DG TRADE)
Regulatory cooperation statement: Canada has a very large geographical territory, which necessarily entails long distance transport of animals for multiple purposes, but which poses unique challenges. Animal welfare in general remains an issue of ongoing public concern. Canada looks forward to all opportunities to understand how other jurisdictions are handling these issues and to share our learnings.
The European Union is also interested in Canadian experience on this topic and information sharing between Canada and the EU will facilitate a better understanding of the benefits and challenges of both systems.
Initiative: information sharing regarding various animal welfare issues (e.g. long distance transport, slaughter and farming).
- Information sharing on Canada’s and the EU’s agenda on animal welfare (e.g. actions on animal welfare under the Farm to Fork Strategy)
- Information and experience sharing regarding long-distance transport of animals (e.g. rules & protocols for feed/water/rest stops, experience with carriers for various species, and resulting animal welfare outcomes)
- Improved appreciation of the respective approaches to animal welfare of Canada and the EU, and applicability to long distance transport of animals
- Information sharing regarding animal welfare outcomes in relation to slaughter.
- Une meilleure appréciation des approches respectives du Canada et de l’UE en matière de bien-être animal et de leur applicabilité au transport des animaux sur de longues distances.
- Échange d’information concernant les résultats en matière de bien-être animal en ce qui concerne l’abattage.
|Tele-conference - Technical information exchange between EU and Canada.||November 2019||Completed – February 2020||Identified a need for further information exchange.|
|Video-conference - Technical information exchange between EU and Canada.||17 February, 2020||Completed||Topics discussed included long distance animal transport, mobile slaughterhouses, and latest developments on animal welfare in both Canada and EU, possible future topics (e.g. labelling).|
|Information and document sharing||February – November 2020||Ongoing||COVID delays moved meeting plans to the fall|
|Video-conference – Continued technical information exchange between Canada and the EU||November 26, 2020||Completed||Information sharing on Canada’s and the EU agenda on animal welfare; long distance animal transport and protection at slaughter (e.g. maximum shackling times and electrical parameters for waterbath stunning of poultry)|
|Video-conference Continued technical information exchange between Canada and the EU||June 16, 2021||Completed||Successful meeting held, with reporting of significant EU initiatives in progress (European Citizen Initiative “End the cage age”; evaluation of the EU Animal Welfare Strategy (2012-2015), further exchanges on animal transport (sea transport)|
Agreed to follow up with exchange of information by Canada and the EU.
Next meeting to be planned for fall of 2021.
EU and Canada also developed a joint cooperation statement on animal welfare , in reference to the recent 2021 Canada-EU Summit.
Sector: Pediatric Medicines
Canadian department: Health Canada
European department: European Commission, Directorate-General Health and Food Safety (DG SANTE) & European Medicines Agency (EMA)
Regulatory Cooperation Statement: Canada is seeking to learn from and increase regulatory harmonization with EMA’s pediatric regulations (EC No 1901/2006 and EC No 1902/2006).
Initiative: Increase regulatory alignment with EMA’s pediatric regulations and processes to improve access to pediatric medicines and to reduce burden on industry.
Health Canada (HC) is developing regulatory and policy initiatives to better support access to medicines for children. Drugs with pediatric indications or formulations that are available in Europe are not always submitted to Canada, possibly due to Canada’s small market size. In addition, while the EU has regulatory authorities that require the submission of a Paediatric Investigation Plan for a drug to be authorized, Canada does not currently have the same requirements. Work to address this second gap is in development.
Further collaboration with the EU on pediatric medicines may be beneficial, based on existing models of international collaboration and worksharing, which HC has been developing over the past few years, such as:
- Access Consortium: In partnership with Australia, Switzerland and Singapore, and, most recently, the United Kingdom, HC has shared review work in order to create efficiencies, and to result in simultaneous drug approvals across multiple jurisdictions, while still taking independent regulatory decisions according to each country’s own legal frameworks.
- Project Orbis: HC has participated in parallel reviews with the US Food and Drug Administration (FDA), which have allowed for the sharing of information and expertise and aligned approval times.
Partnership between HC and the European Medicines Agency (EMA) in pediatrics would support international alignment in regulatory review and, potentially, aligned review processes, thus reducing burden on industry to meet unique requirements in both jurisdictions and potentially eliminating multiple requests for information from both regulators. This would be an attractive pathway for industry looking to follow efficient review processes, and would ultimately result in greater access to medicines for more children worldwide.
|General collaboration through EMA-FDA-HC-TGA (Therapeutic Goods Administration, Australia)-PMDA (Pharmaceutical and Medical Devices Agency, Japan) Paediatric Cluster discussions||Ongoing||Ongoing||No set expiry date|
|EMA to share review templates / internal documentation related to the review of Paediatric Investigation Plans (PIPs) with HC||June 2021 – June 2022||Ongoing||Some delay due to shifting priorities (COVID-19). This work has begun. EMA shared a first batch of information in January 2021. HC will determine specific additional areas of interest.|
|EMA to share internal standard operating procedures (SOPs) and processes related to the review of PIPs (from pre-submission meetings to market authorization)||June 2021 – June 2022||Ongoing||Some delay due to shifting priorities (COVID-19). This work has begun. EMA shared a first batch of information in January 2021. HC will determine specific additional areas of interest.|
|EMA to share finalised PIP reviews (for pharmaceuticals and biologics)||June – December 2022||Ongoing||Dependent on need to redact personal data in documents (clarification ongoing). Business continuity due to COVID-19 and related capacity constraints to be considered.|
|HC to attend EMA’s Paediatric Committee (PDCO) meetings (as an observer, without being involved in the review process)||October 2020 and ongoing||Ongoing||Participated in the October 2020 PDCO meeting and found it to be a very valuable experience. Ongoing attendance will continue on an ad hoc basis.|
|HC to participate in parallel reviews / shadow the EMA in the review of PIPs from submission to approval, including participating in / observing the PDCO meeting(s)||Logistics to be discussed further in 2nd half of 2021 with expected implementation in late 2022.||Not yet started||Dependent on need for PIP redactions (above). Business continuity due to COVID-19 and related capacity constraints to be considered.|
|HC and EMA to share relevant analyses of international pediatric drug approvals/activities developed as part of its ongoing paediatric policy development process||Ongoing||Ongoing||HC shared its Paediatric Drug Action Plan and a draft version of a proposed paediatric regulation for comment in early 2021. HC and EMA to set-up monthly check-ins to share updates and discuss this workplan item.|
|HC and EMA to explore further collaboration options||Initial discussion in late 2021 / early 2022||Not yet started||Experiences from above actions to be assessed. Business continuity due to COVID-19 and related capacity constraints to be considered.|
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