Molly Bowman
Editorial Director, Generic and Investigational Drugs

Clarivate Analytics

Regulatory
Steady progress continues in the efforts of international regulatory convergence. In order to combat repetitive submissions in numerous regions requiring multiple inspection visits, the EU and USA have an ongoing mutual reliance initiative. The end goal of this convergence is to see facilities in Europe inspected solely by EU inspectors, and facilities in the US solely inspected by US inspectors. Currently, this mutual reliance is focused on surveillance inspections, but according to the FDA, the initiative is making progress.

In the first quarter of 2017, some of the US FDA enforcement actions included warning letters issued to active ingredient facilities belonging to Megafine Pharma Ltd., Chongqing Pharma Research Institute Co., Ltd., Resonance Laboratories Pvt. Ltd., CTX Life Sciences Pvt., Ltd., Porton Biopharma, Limited, and Suzhou Pharmaceutical Technology Co., Ltd.

The US FDA is also planning a more robust DMF review program, which would have new efficiencies and better coordination with ANDA review process as part of the GDUFA II legislation. In 2016, manufacturers based in India continued to be the dominant filer of Ty ...