Guidance for market authorization requirements for COVID-19 vaccines: Quality, manufacturing and lot release requirements
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COVID-19 vaccines must be manufactured under good manufacturing practices (GMP) conditions. These conditions must be in line with international requirements, which are outlined in the International Council for Harmonization Q7A guideline and applicable Health Canada guidance.
We require sufficient data to demonstrate that the manufacturing process is well controlled and consistent. This involves details on the manufacturing process for both the drug substance and drug product, including information on:
- assay validation
- source materials
- virus and cell banks
- drug substance and drug product stability
- in-process control testing based on specifications developed to evaluate critical process parameters
Data should be collected in a sufficient number of batches to demonstrate process consistency.
Authorization will also require establishment of stability parameters and expiry date on the drug product in its final container and formulation.
Establishment licensing and good manufacturing practices
To bring a COVID-19 vaccine to market in Canada, a company must have a Drug Establishment Licence (DEL) to fabricate, package/label, test, import, distribute or wholesale a health product. A DEL is issued under the Food and Drug Regulations.
A company without such a licence must apply for one.
During the DEL application review process, a company must demonstrate compliance with GMP. Depending on several criteria, including where the building is located, a company can demonstrate GMP compliance through:
- a Health Canada on-site inspection
- a certificate of GMP compliance issued by a partner with whom Health Canada has a mutual recognition agreement
- an inspection report from a regulatory authority, qualified authority, the WHO or, in some cases, a corporate/consultant auditor
Evidence requirements to support GMP compliance of foreign buildings is included in the guidance how to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080).
If you're unable to obtain documents outlined in GUI-0080 due to the pandemic, please email us at firstname.lastname@example.org. You should contact us before you send in your DEL application. Be sure to include "COVID-19" in your subject line.
Licensing decisions are based on the materials submitted in the application. Timelines for the expedited review are determined on a case-by-case basis and will consider the necessity of the drug in addressing urgent COVID-19-related health needs.
To reduce burden and duplication, finished product testing requirements in section C.02.019 do not apply to importers and distributors of a COVID-19 drug that is subject to the lot release program requirements.
Biologic drugs in Canada are subject to lot release program requirements as outlined in section C.04.015 of Canada's Food and Drug Regulations. Vaccines are considered biologic drugs and are generally subject to the highest level of regulatory oversight since they're administered to healthy children and adults.
Health Canada's lot release program allows the application of a flexible, risk-based approach. This approach considers the evidence on manufacturing quality and controls as a whole, as well as testing from other international regulatory authorities. For example, Health Canada is an associate member of the European Official Medicines Control Laboratory network, which supports the sharing of testing data among its members.
Health Canada's lot release program covers both the pre- and post-market stages for biologic drugs. Each lot of a biologic drug is subject to the lot release program before sale. We base the level of regulatory oversight (testing and/or protocol review) on the degree of risk linked to the product.
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