Just as the ICH steering committee and expert working groups are discussing next steps for the implementation of Q10 Pharmaceutical Quality System and possible adoption of the Q8 annex to Pharmaceutical Development in Brussels this week, ASEAN’s* harmonization scheme is taking another divergent turn.
An article in the November Regulatory Focus discusses the Southeast Asian association’s harmonization efforts, which Malaysia, a member state, initiated in 1992 (note that the first ICH meeting was in 1990). The association established a Pharmaceutical Product Working Group (PPWG) in 1999 to develop harmonized pharma regulations and a common technical document for ASEAN member states. Since then, the group has consulted with ICH and even adopted applicable ICH guidelines and procedures. And although I’m happy to report that ASEAN did not completely go out on its own—it did rely on already existing ICH documents as well as US and UK pharmacopeias—it strikes me as odd that ASEAN would not just join ICH. Why not participate in the international body?
ASEAN issued a new common technical dossier (for the registration of pharmaceuticals for human use) that is to be implemented in 2009, according to the Regulatory Focus article. Its format and structure are similar to that of the ICH common technical document (CTD) but different enough that the dossier cannot be easily formatted for those drug manufacturers working globally. The list of drugmakers without a multinational presence, as we know, is growing shorter every day.
This begs a second question. Why would ASEAN go through all the extra work of managing a pharmaceutical group and developing guidance and documentation that already exist and have been agreed upon by market-leading countries (i.e., the United States, Europe, and Japan)? Why not just adopt the ICH CTD version?
The other day, PharmTech’s editor-in-chief shared a related story with me about her recent trip to China for the Interphex China show. She relayed that SFDA officials seem intent on developing their own guidance and GMP practices rather than borrowing from FDA or EU. Aside from Japan, an ICH member, it seems as though the majority of Asian countries are determined to be as independent as possible when it comes to the pharmaceutical industry and regulation. As Thomas Friedman, author of The World is Flat, would argue, there simply is no justification for this approach or attitude anymore.
*ASEAN stands for the Association of Southeast Asian Nations. The association’s roots are tied to economic unity and date back to 1967. Today, the association consists of Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam.