As mentioned over the last few years, Japan is trying hard to fix its drug lag problem and provide more drug products, more quickly, to its rapidly aging population. At a June 6 MHLW meeting, two new programs were discussed. The first program includes withdrawing conditional approval requirements when Phase 3 studies are not possible. Right now, in Japan, drugs can be approved on a conditional basis, but there are a lot of other requirements to get full drug approval. The MHLW wants to move closer to the US/EU requirements where if a drug shows strong efficacy that outweighs the risks, drugs can be approved without conditional approval. In addition, Japan is now considering the US FDA’s single patient IND program too.
For the second program, Japan’s MHLW currently approves drugs only with specific clinical trial data. Real World Data (RWD) has not been used to any large extent – even though it has become more prevalent in other global markets. Future policies may include supplementing randomized controlled trials with RWD for drug approvals. Also, in cases of short supplies of needed drugs, foreign drugs may be allowed to be imported and sold without Japanese registration (in foreign packages and with foreign-label languages) if needed.
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.