As previously reported, on December 9, 2017, Heath Canada released proposed amendments to the Food and Drug Regulations and Medical Devices Regulations providing for the public release of clinical information contained in drug submissions and medical device applications. On April 10, 2018, Health Canada published a draft guidance document addressing implementation of the proposed amended regulations. According to the guidance:
- Implementation will occur in 4 phases to take place over 4 years. In the first phase, Health Canada plans to proactively publish clinical information contained in any (i) new drug submission (NDS) for a new active substance, (ii) supplemental new drug submission (SNDS) containing confirmatory trials, or (iii) application to switch an authorized medicinal ingredient to non-prescription status. By year 4, this will expand to clinical information in any NDS, SNDS, abbreviated new drug submission (ANDS), or supplemental abbreviated new drug submission (SANDS) as well as any Class III or IV medical device application.
- Upon issuance of a negative regulatory decision, the publication process will be delayed 30 days for the manufacturer to seek reconsideration or an appeal. Publication will be initiated upon completion of any reconsideration or appeal.
- The manufacturer will be notified by email of the list of documents that will be publically released and will have 20 days to propose redactions and de-identify the data. Data anonymization must be explained in a separate “Anonymization Report”.
- Redactions may be proposed for certain categories of clinical information that remain confidential business information (previously reported).
- Clinical information from past submissions will be available upon request through Health Canada’s clinical information portal.
Health Canada is seeking stakeholder comments on the draft guidance, which may be submitted until June 25, 2018.