Author: Pinky Mazumder
What are CEPs
Certificates of Suitability (CEPs), issued by the European Directorate of Quality of Medicines and Healthcare (EDQM), are used to support the safety and efficacy of drugs. In the Health Canada guidance on Use of Certificates of Suitability as Supporting Information in Drug Submissions, CEPs can be submitted by applicants/sponsors in place of complete manufacturing information or the restricted portion of a Type 1 Active Substance Master File (ASMF)1. However if the CEP is not considered supportive, Health Canada can request complete Active Pharmaceutical Ingredient (API) manufacturing information, and can also access the assessment reports from the EDQM if necessary. It is important to note that CEPs are not evidence of Good Manufacturing Practice (GMP) compliance for APIs.
When does it apply
The Health Canada guidance on Use of Certificates of Suitability as Supporting Information in Drug Submissions applies to APIs in New Drug Submissions (NDS) and its supplement, Abbreviated New Drug Submissions (ANDS) and its supplement, Clinical Trial Applications (CTA), and Veterinary Drug submissions.
What to submit
For Health Canada, CEPs and required attestations from the manufacturer are filed in Section 1.2.3 of Module 1 Administrative and Product Information. Written attestations from the manufacturer refer Health Canada to the CEP and assessment report, and attest to providing the entire EDQM dossier upon Health Canada’s request. The manufacturer is also required to provide attestations regarding the manufacture and testing of the API. Such attestations among others, include the assurance of no significant changes in the manufacturing method and controls after issuance of the CEP.
Moreover, a drug submission using a valid CEP for supporting information requires the submission of a fully completed Module 2.3 Quality Overall Summary of Module 2, however not all the sections in Module 3 Quality are required to be submitted. The Health Canada guidance document highlights specific Quality sections that are required for such a submission. Such sections include Section 3.2.S.2.2(a) where a chemical flow diagram is to be submitted, however detailed sections in Section 3.2.S.2.2 – 3.2.S.2.6 is not required. Similarly, documentation from 3.2.S.6 Container Closure System also does not need to be submitted, as long as re-test period and packaging is mentioned in the CEP. From Section 3.2.S.4 Control of Drug Substance, analytical methods and their validations reports from the manufacturer are to be submitted if they differ from the methods authorized by the EDQM. In addition for new applications, Batch Analyses for two batches should be submitted in 3.2.S.4 as well. For complete information on the eCTD section requirements when using CEPs as supporting information, please see the Health Canada guidance on Use of Certificates of Suitability as Supporting Information in Drug Submissions provided in the reference section below.
Alternatively, CEPs may also be provided as partial support for a drug submission and expedite the process. The guidance highlights specific cases where they can serve as partial support.
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Reference
Use of Certificates of Suitability as supporting information in Drug Submissions https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/chemical-entity-products-quality/use-certificates-suitability-supporting-information-drug-submissions_08_24-eng.pdf