FDA, Health Canada to Have First Harmonization Meeting

The FDA and Health Canada are seeking industry feedback on 23 global guidelines ranging from common technical documents to postmarket safety reports and nonclinical and clinical data, ahead of a May 15 meeting at the FDA’s White Oak, Md., campus.

The public meeting — the first since the regulators formed a joint regulatory cooperation council in 2011 — will focus on development of International Conference on Harmonisation guidelines still on the drawing board, with the aim of coordinating the agencies’ positions. The next ICH meeting is in June in Fukuoka, Japan.

Topics still under discussion in the ICH, in addition to CTDs, safety reports and data,  include assessment of systemic exposure in toxicity studies, elemental impurities and good manufacturing practices for active pharmaceutical ingredients and total product lifecycle management, among others.

BIOTECanada President and CEO Andrew Casey hopes to see more joint efforts in approving clinical trial protocols and the resulting data. Both the U.S. and Canada have fairly stringent regulatory systems, and there’s no reason to reinvent the wheel by insisting that a drug that sees approval in one country go through the entire process a second time in the other, he said.

“Leukemia is the same leukemia you have in the U.S., and the faster you can get innovation through the regulatory process and to patients in a safe and effective way, the better off everyone is going to be,” he says.
The council was formed to synchronize U.S. and Canadian drug regulations. 

Comments on the upcoming meeting are due to HPFB_ICH_DGPSA@hc-sc.gc.ca by May 15. — Lena Freund