As mentioned in our October newsletter, the Korean MFDS drug review time is significantly longer than in other global markets. To help solve this problem, the MFDS is planning a new program in January to increase its drug review fees from about 6,000 USD to over 300,000 USD. Their goal is to help fund more qualified reviewers and improve the review process. This is a 50x increase, and foreign drug companies in Korea requested a suspension of the Korean government’s “Innovation Plan for Drug Approval.”
As a result, the Korea Research-based Pharma Industry Association (KRPIA), has said that this program will create a large “weight” on industry. They said that while there is a need for reform in the MFDS drug approval system, a consensus must be reached before such a policy is implemented. They recommended that a 6-month grace period be put into effect before these fees will increase. They also requested that the drug approval fee be reduced for drugs with the same contents. In addition, they want to exempt rare disease drugs from this new fee system and also waive the fee for re-application if the drug dossier is voluntarily pulled back.
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.