FDA, Health Canada Look to Implement Common Electronic Submission System

Regulatory NewsRegulatory News
| 09 August 2016 | By Zachary Brennan 

As part of efforts to further align the US Food and Drug Administration (FDA) and Health Canada, both sides are working to implement a common electronic submission gateway to allow pharmaceutical companies to submit large electronic documents simultaneously to both regulators.

The collaborative effort is just one of a number of joint action plans the two sides are planning as part of the Canada-US Regulatory Cooperation Council (RCC), which aims to increase collaborations between the drug and device regulators.

Expansion of the electronic gateway across all human pharmaceutical and biologics submission types requires a phased approach and is expected to be completed at the end of 2016.

In addition to the common gateway, both FDA and Health Canada are looking to increase mutual reliance on each other’s surveillance of good manufacturing practice (GMP) inspection reports to avoid duplication, develop and adopt common monographs for routine over-the-counter drugs (not expected until 2017) and alongside the US Occupational Safety and Health Administration, to further align common classification and labeling requirements for workplace hazardous chemicals.

“Increased collaboration between regulatory agencies in Canada and the U.S. will reduce unnecessary duplicative costs for manufacturers of pharmaceutical and therapeutic products, further streamline regulatory decision-making, and minimize the delays in bringing health and personal care products to the marketplace, thereby expanding consumer choice without compromising the safety, efficacy and quality of products,” a joint action plan for the RCC says.

Other Initiatives, Past Work

Through December 2017, Health Canada and FDA also are working to align their thinking on guidance documents from the International Council on Harmonisation (ICH) via joint public consultation meetings that are expected in September 2016, April 2017 and September 2017.

Both regulators are also working with the Pharmaceutical Inspection Cooperation Scheme (PIC/S) and the International Coalition of Medicines Regulatory Authorities (ICMRA).

With PIC/S, both sides are able to see and use a master list of over 2,300 planned inspections planned by PIC/S members, and FDA and Health Canada are informed of each other’s schedule of foreign inspections. FDA and Health Canada will explore the possibility of performing joint inspections of foreign sites of common interest with other PIC/S members (as they did here).

And on the ICMRA end, FDA and Health Canada are working to share more information on pharmaceutical GMPs and exploring ways to increase mutual reliance on GMP assessments, which is an area where FDA and EMA are also making progress.

On the device side, Health Canada in 2015 expanded the scope of electronic labeling, in order to better align with FDA, and to enable manufacturers to provide directions for use electronically for devices that are not sold to the general public.

Health Canada and FDA Work Plan

United States Food and Drug Administration and Health Canada Regulatory Partnership Statement

Work Plan: Medical Devices

Work Plan: Over-the-Counter Products


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