Procedure for Evaluating New Regulatory Authorities

Administrative Arrangement under Article 15.3(f) of the Protocol on the Mutual Recognition of the Compliance and Enforcement Programme regarding Good Manufacturing Practices for Pharmaceutical Products

This administrative arrangement is not intended to create rights or obligations under international or domestic law and, in line with Article 15(7) of the Protocol, is not subject of the provision of Chapter 29 of the CETA Agreement.

Between DG SANTE and Health Canada

Friday, November 16, 2018

DG Santé is a Directorate General of the European Commission.
Health Canada is a Federal department of the Government of Canada.

This administrative arrangement has been approved by the European medicines Agency (EMA) and the competent authorities of the Member States.

1.   Introduction

The Equivalence of new regulatory authorities is one of the main elements of the CETA Protocol to the Mutual Recognition of the Compliance and Enforcement Programme regarding Good Manufacturing Practices for Pharmaceutical Products (CETA GMP Protocol) which the Participants, through the Joint Sectoral Group (JSG), are required to establish under Article 12 of the CETA GMP Protocol through an Administrative Arrangement pursuant to Article 15.3(f)(Procedure for Evaluating New Regulatory Authorities).

This Administrative Arrangement sets out the operational arrangements to fulfil the requirements of Article 12.

Article 12

Equivalence of new regulatory authorities

1. A Party ("requesting Party") may request that a regulatory authority in its territory that is not recognised as equivalent to regulatory authorities in the other Party ("evaluating Party"), be evaluated to determine whether it should be recognised as equivalent.  Upon receiving the request, the evaluating Party shall conduct an evaluation pursuant to the procedure for evaluating new regulatory authorities under the GMP Administrative Arrangement referred to in Article 15.3.

2. The evaluating Party shall evaluate the new regulatory authority by applying the components of a GMP compliance programme under the Administrative Arrangement referred to in Article 15.3. The components of a GMP compliance programme must include such elements as legislative and regulatory requirements, inspection standards, surveillance systems and a quality management system.

3. If, upon completion of its evaluation, the evaluating Party determines that the new regulatory authority is equivalent, it shall notify the requesting Party in writing that it recognises the new regulatory authority as equivalent.

4. If, upon completion of its evaluation, the evaluating Party determines that the new regulatory authority is not equivalent, the evaluating Party shall provide to the requesting Party a written justification demonstrating that it has well-founded reasons for not recognising that the new regulatory authority is equivalent.  At the request of the requesting Party, the Joint Sectoral Group on Pharmaceuticals ("Joint Sectoral Group") referred to in Article 15 shall consider the evaluating Party’s refusal to recognise the new regulatory authority as equivalent, and may provide recommendations to assist both Parties to resolve the matter.

5. If, upon completion of its evaluation, the evaluating Party determines that the new regulatory authority is only equivalent for a more limited scope than that proposed by the requesting Party, the evaluating Party shall provide to the requesting Party a written justification demonstrating that it has well-founded reasons to determine that the new regulatory authority is only equivalent for the more limited scope. At the request of the requesting Party, the Joint Sectoral Group shall consider the evaluating Party’s refusal to recognise the new regulatory authority as equivalent, and may provide recommendations to assist both Parties to resolve the matter. 

6. A regulatory authority recognised as equivalent under the Agreement on Mutual Recognition Between the European Community and Canada, done at London on 14 May 1998, is recognised as equivalent under this Agreement from its entry into force.

2.   Purpose

The purpose of this Administrative Arrangement is to outline the proceduresfor evaluating new regulatory authorities (RA) referred to inArticle 12 of the CETA GMP Protocol on the mutual recognition of the compliance and enforcement programme regarding good manufacturing practices for pharmaceutical products.  Specifically, Article 12 sets out the procedure to determine whether a regulatory authority that is not recognized as equivalent could be determined to be equivalent with respect to its GMP Compliance Programme.

3.   Scope and Application

This Administrative Arrangement is applicableto the Requesting Participant (RP) whose RA is not yet recognized as equivalent to the Evaluating Participant (EP) and to the RA of the Participant that is requested to perform the equivalency evaluation. The Participants to this Administrative arrangement are the Regulatory Authorities of the EU on the one side, and Canada on the other side.

4.   Evaluation Procedure

The evaluation procedure consists of three general steps before a Participant determines whether a RA of the other Participant is equivalent: documentation review, on-site assessment, and reporting process.  A decision on equivalencyis made as per Article 12 (3), (4) and (5) of the CETA GMP Protocol. The decision on equivalency will be followed by an operational phase initiated between the Participants.

A.  Documentation Review

B.   On-Site Assessment

C.   Reporting Process

D.  Initiation of the Operational Phase

Summary overview of the assessment process

StepWho
1.Request for assessmentRP
2.Organize an introductory teleconference with RPEP
3.Provide self-assessment and the complete supporting documentation requested by EPRA
4.Finalize documentation review (or written rationale if no on-site visit)EP
5.Inform the RP whether proceeding or not with the on-site assessmentEP
6.Organize and conduct the on-site assessment, if applicableEP
7.Provide final inspection reports from observed inspections to EPRA
8.Provide a draft evaluation report to RP after review of the inspection reportsEP
9.Provide comments on the draft evaluation report and corrective actions to EPRA
10.Finalize the evaluation report and inform RP and JSG of the main conclusion and equivalence decisionEP
11.Initiation of the Operational PhaseEP & RP
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