Recent Health Canada developments include:
Advisory Council on the Implementation of National Pharmacare
Health Canada and health technology assessment organizations (HTAs) to align reviews
On June 22, 2018, the Notice to industry: Aligned reviews between Health Canada and health technology assessment organizations was released, which provides an option to biological and pharmaceutical new drug submission sponsors to seek an aligned review between Health Canada and the Canadian Agency for Drugs and Technologies in Health (CADTH) and l’Institut national d’excellence en santé et en services sociaux (INESSS) (collectively, the HTAs). According to the notice, these aligned reviews are expected to reduce duplication and time lags between Health Canada market authorization and HTA recommendations.
TPD, BGTD and NNHPN Annual Performance Reports released
The Therapeutic Products Directorate (TPD), the Biologics and Genetic Therapies Directorate (BGTD), and the Natural and Non-Prescription Health Products Directorate (NNHPD) have released their Drug Submission Performance Annual Reports for Fiscal Year 2017-2018. The reports contain information regarding pharmaceutical, biologic and radiopharmaceutical drug submission review activity in 2017-2018, including approval times.
Drug and Medical Device Highlights 2017
This Health Canada report includes numbers of new drugs and medical devices approved, brief details of approvals, the number of various post-market surveillance report and 2017 accomplishments.
Revised Guidance Documents on Post-Notice of Compliance (NOC) Changes
On June 26, 2018, Health Canada published notice of the revised Guidance Document: Post-Notice of Compliance (NOC) Changes – Framework and notice of the revised Guidance Document: Post-Notice of Compliance (NOC) Changes – Safety and Efficacy. These Guidance Documents clarify when Level III changes should be filed, and reflect changes implemented over the past several years, including safety changes under Vanessa’s Law and changes to Plain Language Labelling requirements.
Revised Summary - Cancellation of a Drug Identification Number (DIN) and Notification of Discontinuation of Sales
As previously reported, Health Canada released a Guidance Document to facilitate compliance with provisions requiring notification upon discontinuance of the sale of a drug. On June 13, 2018, the Guidance was updated (Guidance Document: Cancellation of a Drug Identification Number (DIN) and Notification of Discontinuation of Sales), including to address the recent Regulations Amending the Food and Drug Regulations and the Regulations Amending the Food and Drug Regulations (DIN Requirements for Drugs Listed in Schedule C to the Food and Drugs Act that are in Dosage Form) relating to the Minister’s powers to require assessments, tests and studies, as reported here. We have updated our previously published chart (An Update on Vanessa’s Law) to include this Guidance.
Guidance Document on Notifying Health Canada of Foreign Actions
As previously reported, Health Canada had released a draft Guidance Document to provide clarity on when to report foreign incidents in accordance with Vanessa’s Law. On July 12, 2018, Health Canada released a further revised Guidance, Notifying Health Canada of Foreign Actions – Guidance Document for Industry. We have updated our previously published chart to include this Guidance.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.