Striving for greater alignment in regulatory approaches, both FDA and Health Canada are continuing work to put in place the Common Electronic Submissions Gateway (CEGS) to allow industry to submit simultaneously to both regulators. Full functionality is expected to be completed at the end of 2016. CEGS is one initiative of the Canada-US Regulatory Cooperation Council (RCC). RCC also has other Joint Action Plan Initiatives in developing common monographs for routine OTC drugs and teaming up to eliminate duplicate efforts on routine surveillance of GMP inspection reports.
“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.
For more details and links, check out Zachary Brennan’s article in RAPS.