Asian medicines agencies are joining those in the US and Europe in seeking to address the emerging regulatory challenges posed by: ● new classes of products such as cell-based regenerative medicines and engineered antibodies ● accelerated approval pathways ● biosimilars ● international convergence, and ● validation lifecycle management.
Regulators from Asia provided insights on their agencies’ strategies for dealing with these pressing issues and the progress they have made to date at the CMC Strategy Forum Japan, held in Tokyo in December 2014.
Sponsored by CASSS with the support of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) as well as the Japan Pharmaceutical Manufacturers Association (JPMA) and the U.S. FDA, the forum provided the opportunity for regulator and industry experts from Asia to compare notes with those from the US and Europe on where viable solutions and harmonization pathways lie and the hurdles that have to be crossed to achieve them.
[CLICK HERE for the complete story. Included is an in-depth summary of the forum discussions provided at its conclusion by industry consultant Nadine Ritter. Nonsubscribers can get information on IPQ subscription/ licensing and individual story purchasing by contacting Peter Blachly (peter@IPQpubs.com).]