U.S. FDA and Health Canada Advance Joint Electronic Submissions Gateway Initiative

To further enhance collaboration between the U.S. FDA and Health Canada, both parties are working to implement a common Electronic Submissions Gateway (ESG), enabling pharmaceutical companies to submit large electronic documents to both the U.S. FDA and Health Canada simultaneously.

This collaboration is just one of a series of joint action plans currently being planned by both parties, as part of the work of the U.S.-Canada Regulatory Cooperation Council (RCC), aimed at enhancing collaboration between the two drug and medical device regulatory agencies.

Expanding the electronic submission channel to cover all types of human drug and biologic applications will require a phased approach, which is expected to be completed by the end of 2016.

In addition to the common electronic submission channels, the U.S. FDA and Health Canada are also committed to: enhancing mutual trust in each other’s GMP inspection reports to avoid duplication of efforts; developing and selecting common OTC monographs for routine over-the-counter drugs (expected to be realized only by 2017); and further harmonizing the universal classification and labeling requirements for hazardous chemicals in the workplace together with the U.S. Occupational Safety and Health Administration.

“Growing collaboration between Canadian and U.S. regulators can save manufacturers of drugs and medical products from unnecessary duplicative costs, further streamline regulatory decision-making, and minimize the time required to bring health and personal care products to market, thereby expanding consumer choice without compromising product safety, efficacy, and quality,” stated the U.S.-Canada Regulatory Cooperation Council (RCC) in a joint action plan.

The U.S. FDA and Health Canada are currently working to harmonize their positions on International Council for Harmonisation (ICH) guideline documents through joint public consultation meetings scheduled for September 2016, April 2017, and September 2017.

The U.S. FDA and Health Canada are currently collaborating with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the International Coalition of Medicines Regulatory Authorities (ICMRA).

In collaboration with the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the U.S. FDA and Health Canada have access to and utilize a master list of more than 2,300 planned inspections scheduled by PIC/S members. Furthermore, the U.S. FDA and Health Canada share their respective foreign inspection schedules with each other. The U.S. FDA and Health Canada will explore the possibility of conducting joint inspections of foreign manufacturers of mutual concern in conjunction with other PIC/S members.

Within the framework of the International Coalition of Medicines Regulatory Authorities (ICMRA), the U.S. Food and Drug Administration (FDA) and Health Canada are working to share more information on Good Manufacturing Practice (GMP) for pharmaceuticals and to explore ways to enhance mutual reliance on each other’s GMP assessment outcomes—an area also being actively advanced by the U.S. FDA and the European Medicines Agency (EMA).

In the area of medical devices, Health Canada expanded the scope of electronic labeling in 2015 to better align with the U.S. FDA and to enable manufacturers to provide electronic instructions for use for devices not sold directly to the public.

Original Source:RAPS