Health Canada has launched a consultation on proposed amendments to the Food and Drug Regulations and Medical Devices Regulations (the Regulatory Amendments). Consultation on the Regulatory Amendments, which have been published in the Canada Gazette, Part 1, is open until March 27, 2023.
The Regulatory Amendments build upon the regulatory flexibilities introduced in the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (IO), which allowed the Minister of Health (Minister) to apply terms and conditions on drug approvals and allowed for rolling reviews for drug and vaccine submissions. We previously reported on the IO here.
Regulatory Amendments
Briefly, the changes made by the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) would include:
- using terms and conditions on drug approvals (e.g., to require information on the drug post-approval);
- broadening the scope of terms and conditions used for Class II, III and IV medical devices;
- allowing rolling reviews of certain drug submissions, including for drugs intended to address a public health emergency or an unmet medical need (e.g., no other indicated product on the Canadian market);
- requiring risk management plans for higher-risk human drugs, including for drugs that have already been authorized;
- removing outdated product-specific regulations for biologics and replacing them with more general requirements;
- updating the requirements for certain drugs that claim a manufacturer’s standard (e.g., biologics);
- repealing requirements for labelling of the standard for specific drugs;
- clarifying the Minister’s authority to consider information obtained outside of a new drug submission; and
- requiring manufacturers to submit clinical trial data broken down by population subgroups (disaggregated data) for new and supplemental human drug submissions.
Guidance documents
Health Canada is receiving comments on a number of proposed new guidance documents that support the Regulatory Amendments, including:
- Guidance on terms and conditions (T&Cs) for human and veterinary drugs
- Guidance on management of rolling reviews for drug submissions
- Guidance on the collection and analysis of disaggregated data in clinical trials
- Guidance on the Food and Drug Regulations for public health emergency drugs
- Guidance: Terms and conditions for medical devices
Health Canada is also receiving comments on proposed updates to existing guidance documents that are changing as a result of the Regulatory Amendments, including:
- Guidance: Labelling of pharmaceutical drugs for human use
- Quality (chemistry and manufacturing) Guidance: New Drug Submissions and Abbreviated New Drug Submissions
- Guidance: Submitting risk management plans