Health Canada's use of the European Directorate for the Quality of Medicines and Healthcare's Certificate of Suitability and the signing of a Memorandum of Understanding
Consistent with the approach of the Therapeutic Products Directorate (TPD) of the Health Products and Food Branch (HPFB) of Health Canada, the Veterinary Drugs Directorate (VDD) is formally considering the acceptance of Certificates of Suitability (CEPs) issued by the European Directorate for the Quality of Medicines and Healthcare (EDQM) of the Council of Europe in lieu of conducting an in-house quality assessment of the Closed (Restricted) Part of Drug Master Files for drug substances. It is anticipated that incorporating CEPs into VDD's evaluation of drug substances will lead to a reduction in both review times and in the number of chemistry-related deficiencies noted in the first cycle of review. Furthermore, as pharmaceuticals for veterinary use are authorized for sale under the same regulations as human drugs (Divisions 1, 2 and 8 of the Food and Drug Regulations), extrapolation of this policy to VDD is both reasonable and practical.
The HPFB and EDQM have signed a Memorandum of Understanding that will facilitate cooperation and information exchange with regard to the use of CEPs.
As a consequence, this announcement serves to provide guidance and encourage the filing of CEPs for Active Pharmaceutical Ingredients (APIs) used in drug products reviewed by the Directorate pursuant to Division 8, Part C of the Food and Drug Regulations, with the exception of highly complex substances. This exercise will also allow for greater familiarity in the use of CEPs by VDD.
In accordance with Health Canada guidance, Veterinary Master Files (VMFs) may be filed with VDD in support of Division 8 submissions. Currently, VDD conducts a separate assessment of the 'closed' (restricted) part of a VMF as part of the drug submission review; the open part being reviewed within the body of the submission.
As of this notice, if a CEP is filed in conjunction with a VMF for the same API, producer, site, and manufacturing process, only the open part of the VMF will be evaluated by VDD. The closed part of the VMF, containing details of the manufacture, will not normally be reviewed. For sterile APIs and APIs that have the potential of being contaminated with adventitious agents of human, animal or micro-organism origin, VDD will review the manufacturing processes and controls. In exceptional cases, the EDQM review report may be requested.
It is important to note that the provision of a CEP does not at present replace the option of filing a VMF. In filing a CEP, the following authorizations and attestations are to be submitted concurrently:
- Letter of access authorizing VDD to refer to a VMF in support of a submission (no change);
- Written authorization for VDD to examine the EDQM confidential review report for the drug substance , should the need arise;
- Written assurance that there have been no changes in the manufacturing method following the granting of the CEP, or its last revision, by EDQM; and
- Written assurance that the manufacturing process described in the Canadian VMF is identical to the one evaluated by the EDQM.
Following further experience with the use of CEPs in VDD's review process it is expected that guidance on the full implementation of CEPs will provide drug submission sponsors with a new option of referencing a CEP in their submission, rather than referencing a VMF.
Questions or comments related to this project or notice should be directed to:
Chief, Manufacturing and Chemical Evaluation Division
Veterinary Drugs Directorate
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