This month is quite exciting for those in the pharmaceutical industry paying attention to harmonization and international regulatory efforts—which frankly, should be everyone if your company wants to stay in the game. Last week, PDA/FDA held its annual joint regulatory conference with nearly 20 high-level speakers representing the US Food and Drug Administration, including Dr. Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research. Several European representatives presented as well, including the European Medicine Agency’s Emer Cooke. And to give China’s perspective after a very harsh year due to the heparin contamination, Tang Minhao, deputy director of the Shanghai Municipal Food and Drug Administration, was on site as well. Harmonization was the theme of the conference and both industry and regulators were pumped up about recent progress such as the adoption of ICH Q10: Pharmaceutical Quality System (read reports from the floor). The regulatory conference was followed by a second PDA/FDA meeting focusing specifically on supply-chain issues.

This week, the World Health Organization is holding the 13^th International Conference of Drug Regulatory Authorities in Bern, Switzerland, to discuss everything from proving interchangeability and regulations for biosimilars to anticounterfeiting and inspection information-sharing.

And in two months (Nov. 10–13), the steering committee and expert working groups of the International Conference on Harmonization will gather in Brussels, Belgium, to discuss implementation of ICH Q10, revision of ICH Q8R: Pharmaceutical Development, and several other topics regarding international cooperation. FDA is holding a public meeting to prepare for the ICH gathering on Oct. 21 in Rockville, MD.

Some in industry have been slow to adopt or wary of harmonization efforts, but clearly, it’s the issue everyone is talking about and pursuing worldwide. With a global economy and global pharmaceutical marketplace, there’s really no other direction to go in. Pharmaceutical Technology will be reporting on international cooperation efforts all fall but we’d also like to hear what you think about the subject. Leave a comment below or email the editors at adrakulich@advanstar.com.