Historically, Japanese drug registration lagged approval in the West by a number of years. However, in the last 7 years or so, regulatory changes in Japan have expedited approval there. These changes include more drug reviewers, a simplified approval process, an updated clinical trial review process, etc. However, recently the 3 main pharmaceutical lobbies in Japan recommended that the government revise Japan’s system of drug pricing to foster more drug investment and the development of new drugs. The 3 main pharmaceutical lobbies said without a more formalized pricing system, it would reduce the opportunities for the development of new drugs. There have been over 55 changes in how much drug makers can expect patients and hospitals to pay for drugs since 2014. The 3 lobbies say pricing mechanism fluctuations could lead to a renewed drug lag.
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.
Source used in the article: https://www.reuters.com/business/healthcare-pharmaceuticals/japan-pharma-lobbies-say-pricing-scheme-leading-renewed-drug-lag-2022-05-16/#:~:text=%22The%20Japanese%20market%20is%20losing,to%20enter%20the%20Japanese%20market.