Guidance for market authorization requirements for COVID-19 drugs: Quality and manufacturing requirements
On this page
COVID-19 drugs must be manufactured under good manufacturing practices (GMP) conditions. These conditions must be in line with the international requirements outlined in the International Council for Harmonization Q7A guideline and with applicable Health Canada's guidance.
We require sufficient information to demonstrate that the manufacturing process is well controlled and will consistently produce a drug substance and drug products that are of suitable quality for the intended use. The quality must be maintained up to the time when the product is retested or until the shelf life or expiry date under recommended storage conditions.
Sufficient information includes details on the manufacturing process for both the drug substance and drug product, such as on:
- starting materials
- source materials
- virus and cell banks
- in-process control testing based on specifications developed to evaluate critical process parameters and controls performed on intermediates
For sterile drug substance and drug products, the sterilization process should be validated before the application is submitted. Details of the validated sterilization parameters and, if relevant, sterilization process for the equipment and container closure system should also be provided.
The following information should also be provided:
- specifications for all materials (for example, raw materials, starting materials, solvents, reagents, catalysts) and excipients used in the manufacturing process for the drug substance and drug product
- summary of characterization studies performed to elucidate the structure and function
- polymorphic form and particle size distribution for low solubility drugs, if relevant to the dosage form and drug product performance
- impurities and degradation products as well as their controls (levels should be justified using existing guidelines or toxicology data)
- data from a sufficient number of batches from both the drug substance and drug product, including the drug batch(es) used in the clinical studies
- should demonstrate process consistency and product quality
- for biologics, should also demonstrate comparability between this material and material made at other sites, processes and scales, as applicable
- specifications and summary of the test procedures and validation information for the drug substance and drug product
- critical assays such as potency and impurities should be validated
- proposed container closure systems for the drug substance and drug product, including specifications and a discussion of the suitability of these systems
- stability parameters and expiry date or shelf life of the drug product in its final container and formulation
- stability data from a sufficient number of batches of the drug substance and drug product lots
- drug substance should be stored in a representative container closure system and drug product in the proposed container closure
Also include copies of the following documents:
- for small molecules, executed production documents for the batches used in pivotal clinical studies to confirm that the formulation and manufacturing processes are representative of those proposed for the commercial lots
- for biologics, executed production documents for the commercial process validation lots
- master production documents (in English or French) for each proposed strength, commercial batch size and manufacturing site
Establishment licensing and good manufacturing practices
To bring a COVID-19 drug to market in Canada, a company must have a drug establishment licence (DEL) to fabricate, package/label, test, import, distribute or wholesale. A DEL is issued under the Food and Drug Regulations.
A company without such a licence must apply for one. For instructions on how to apply for a DEL, refer to our:
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 World Health Organization (WHO) or, in some cases, a corporate/consultant auditor
Evidence requirements to support GMP compliance of foreign buildings is included in the following guidance:
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. We 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.
Lot release program
Biologic drugs in Canada are subject to lot release program requirements as outlined in section C.04.015 of the Food and Drug Regulations.
Health Canada's lot release program allows for 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.
The 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. Health Canada bases the level of regulatory oversight (testing and/or protocol review) on the degree of risk linked to the product.
Report a problem or mistake on this page
- Date modified: