The creation of the Consortium allows these regulatory agencies to discuss ways to enhance and even align the regulatory reviews of certain drug products.

On March 1, 2018, the guidance document “Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs” (the “Guidance Document”) came into effect. The Guidance Document applies to drug submissions and applications involving biologics, radiopharmaceuticals, human pharmaceuticals and disinfectants regulated under the Food and Drugs Act. The coming into effect of the Guidance Document will be April 1, 2019 in respect of disinfectant drugs.

In late 2017, the Canadian Agency for Drugs and Technologies in Health (“CADTH”) announced an open consultation on proposed changes to the Common Drug Review (CDR) and pan-Canadian Oncology Drug Review (“pCODR”) for the review of biosimilar drug products. The consultation also addressed the resubmission eligibility criteria for drugs subject to CDR or pCODR along with various administrative changes. On February 2018, CADTH announced new operational changes resulting from the consultation and to enhance the drug review process.

Health Canada is considering a pilot of the Regulatory Enrollment Process (“REP”) using the Common Electronic Submission Gateway (“CESG”) for Medical Device applications in Summer 2018.

On January 19, 2018 Health Canada announced the adoption of the ICH guidance on M7: The Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (the “Guidance”). The Guidance was prepared by the ICH and reviewed by the regulatory bodies during consultations. By adopting the Guidance, Health Canada has endorsed the principles within.

The Ministry of Health and Long-Term Care for the Province of Ontario recently published draft Regulations for the recently enacted Health Sector Payment Transparency Act, 2017 (“HSPTA”). The HSPTA is intended to strengthen transparency in the financial relationships that exist within Ontario's health care system for the ultimate purpose of increasing public trust and confidence.

On November 16, 2017 the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) published a draft guidance on Q12 titled, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. This guidance was established to address certain technical and regulatory gaps found during consultations concerning other ICH Quality guidelines, such as Q8, Q9, Q10, and Q11.

All 13 Provinces and Territories have been working together to achieve greater value for brand name and generic drugs for publicly funded drug programs. These initiatives, formerly known as the Pan-Canadian Pricing Alliance and the Generic Value Price Initiative, are now referenced collectively as the pan-Canadian Pharmaceutical Alliance (pCPA).

Late last year, Health Canada announced the revised validation rules for regulatory transactions in the electronic Common Technical Document (“eCTD”) format.

In late 2017, Health Canada released a draft guidance document to assist sponsors, manufacturers, and importers on the authorization process for investigational testing of medical devices. The draft guidance, titled “Applications for Medical Device Investigational Testing Authorizations”, is open for consultation and supersedes the previous guidance document from 1999 (“Preparation of an Application for Investigational Testing – Medical Devices”).

In late 2017, Health Canada published a new guidance document concerning HIV RDTs, titled “Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests (RDTs) for use at the Point of Care or for Self-Testing” (the “Guidance Documents”). The Guidance Document provides manufacturers of Class IV HIV RDTs for point of care or self-testing applications with specific guidance on the analytical and clinical data as well as labelling considerations as part of the device application process.

Late last year, Health Canada issued a notice to the industry on the reduction of audit times for the Medical Device Single Audit Program (“MDSAP”).