This article explores a number of recent Health Canada developments.
Advisory Council on the Implementation of National Pharmacare
On 20 June 2018 the Advisory Council on the Implementation of National Pharmacare was launched, together with the release of a discussion paper and the opening of a public consultation.
Health Canada and HTAs to align reviews
On 22 June 2018 the Notice to industry: Aligned reviews between Health Canada and health technology assessment organizations was released, which enables biological and pharmaceutical new drug submission sponsors to seek an aligned review between Health Canada and the Canadian Agency for Drugs and Technologies in the National Institute of Excellence in Health and Social Services (collectively, the HTAs). According to the notice, these aligned reviews are expected to reduce duplication and time lags between Health Canada market authorisation 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 the fiscal year 2017 to 2018. The reports contain information regarding pharmaceutical, biologic and radiopharmaceutical drug submission review activity in 2017 to 2018, including approval times.
Drug and Medical Device Highlights 2017 report
Health Canada's Drug and Medical Device Highlights 2017 report includes:
- the number of approved new drugs and medical devices;
- brief details of the approvals;
- the number of various post-market surveillance reports; and
- various 2017 accomplishments.
Revised guidance documents on post-NOC changes
On 26 June 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 guidance on discontinuation of sales
Health Canada recently released a guidance document to facilitate compliance with provisions requiring notification on the discontinuance of a drug's sale.(1) On 13 June 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 (for further details please see "New regulations governing powers to require assessments, tests and studies").(2)
Guidance Document on notifying Health Canada of foreign actions
Health Canada previously released a draft guidance document to provide clarity on when to report foreign incidents in accordance with Vanessa's Law (for further details please see "New regulations governing powers to require assessments, tests and studies"). On 12 July 2018 Health Canada released a further revised guidance document, Notifying Health Canada of Foreign Actions – Guidance Document for Industry.(3)
For further information on this topic please contact Katie Lee at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
Endnotes
(1) Further information is available here.
(2) An updated chart including this guidance is available here.
This article was first published by the International Law Office, a premium online legal update service for major companies and law firms worldwide. Register for a free subscription.
