Last month the ACSS Consortium announced the launch of the Generic Medicines Work Sharing Trial, an innovative work sharing model for the coordinated assessment of applications for generic medicines.

The ICH has published and adopted two new guidance documents relating to drug development.

Bill C-45, the proposed Cannabis Act (the “Act”), was introduced earlier in 2017 and is scheduled to be in force by July 2018. The Act will provide restricted access to cannabis for recreational purposes, as well as regulate its production, importation, exportation, distribution, sale, and possession.

On November 24, 2017 Health Canada published the Guidance Document “Use of a Foreign-sourced Reference Product as a Canadian Reference Product”, for sponsors who are seeking to demonstrate pharmaceutical equivalence and bioequivalence with a Canadian Reference Drug under paragraph (c) of C.08.001.1 of the Food and Drug Regulations. The Guidance Document replaces previous guidance which had been in place since 1995.

The increase in infertility in Canada has seen many Canadians turn to assisted human reproductive technologies to assist with family planning.

On October 30, 2017, Health Canada released the final version of the Guidance Document - Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (“NDS”) and Abbreviated Drug Submissions (“ANDS”)

A significant portion of all healthcare-related expenditures in Canada is attributed to prescription drugs. Despite this, prescription drug costs have continued to rise, with Canada having some of the world’s highest prices for prescription drugs.

Health Canada has released the Guidance Document - Certificate of Supplementary Protection Regulations which provides information for industry regarding the recently implemented Certificates of Supplementary for medicinal ingredients.

Health Canada's guidance document on the Fees for the Review of Drug Submissions and Applications provides sponsors information concerning the fees associated with the review of submissions.

Health Canada recently published the Notice - Patented Medicines Notice of Compliance Regulations as an update for the public regarding the recently implemented amendments to the Patented Medicines (Notice of Compliance) Regulations which came into effect on September 21, 2017 as part of Canada’s obligations under the Comprehensive Economic Trade Agreement with the European Union. 

On September 8th, 2017, the Food and Drug Administration signaled the start of a major regulatory overhaul by publishing a docket in the Federal Register (the “Docket”) requesting input from interested parties regarding unnecessary regulatory burdens

On September 27, 2017, the Government of Ontario tabled a bill to enact the Health Sector Payment Transparency Act, 2017, (the “Act”) which will implement reporting of transfers of value from the pharmaceutical and medical device industries to prescribed recipients.