Medical Product Harmonization Meeting in Japan

Japan recently hosted the APEC Life Sciences Innovation Forum (LSIF) Regulatory Harmonization Steering Committee (RHSC) meeting on March 2-4, 2010. RHSC was established in 2008 to promote a strategic and coordinated approach to regulatory harmonization and capacity building efforts within the APEC region. A harmonized global regulatory system would eliminate redundant reviews and requirements, improving trade and increasing safety for consumers.

Global Harmonization Task Force (GHTF) training has helped encourage adopting GHTF guidance documents. For example, ASEAN (Association of South East Asian Nations) will most likely continue using these documents in the next three to ten years. Countries such as Malaysia, Singapore, Thailand, etc. have revised or are in the process of revising their medical device regulatory schemes based on GHTF principles.

Future APEC/GHTF trainings are planned, including an APEC funding delegation visit to the US and Canada in August 2010. There are also discussions of a possible future APEC Regulatory Harmonization Project with Asia.

The APEC LSIF also has an anti-counterfeit medical products initiative. The hope is to promote the APEC Anti-counterfeit Medical Products Action Plan, based on the seminars presented by US DOC and USFDA in 2008. In addition to proposing detection technologies, the US is planning to work closely with the World Health Organization International Medical Products Anti-Counterfeiting Task Force (WHO IMPACT) in implementing future APEC anti-counterfeit programs.

Participants in the meeting included health authority representatives from Canada, China, Taiwan, Japan, South Korea, Thailand and the US and from pharmaceutical/medical device industry representatives.