Japan and the US have begun negotiating a mutual recognition agreement covering GMP inspections of pharmaceutical manufacturing plants, a step that could ease the regulatory burden on drug makers exporting between the two countries.
Under such a deal, US and Japanese regulators would accept each other’s inspection results rather than conducting separate audits. In practice, that would mean Japanese plants making drugs for the US market could avoid routine FDA inspections, and US facilities exporting to Japan could similarly be exempt from inspections by Japanese authorities, as long as the sites are already cleared in the home country.
Product scope and a timeline for any agreement have not been settled. Japan’s existing GMP mutual recognition agreement with the EU, in force since 2002 and covering chemical drugs, biologics and active pharmaceutical ingredients, is seen as a likely template for the new US-Japan framework. The US already has comparable GMP arrangements with the EU, UK and Switzerland, but none yet with Japan.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.