Japan’s┬áRegulatory Proposals to Improve Drug Market

Japan’s Ministry of Health, Labor and Welfare (MHLW) has proposed several changes to improve the Japan drug market. Most new drugs, even with approval overseas, can take almost 4 years to get approval in Japan. The MHLW plans to decrease this review time to 500 days. As reported in previous eNewsletter issues, the MHLW also plans to increase the number of drug reviewers. Currently, the MHLW only has about 200 staff to handle drug-screening issues.

In addition, the MHLW also proposed deregulation of the drug payment system to permit increased variety of original and generic drugs. Doctors and patients have a greater choice of drugs to choose. The process of going from prescription to OTC in Japan has also become easier for drug manufacturers. Instead of the MHLW being the only party reviewing a Rx-to-OTC application, industry experts and academics can now be involved in the process. With Japanese consumers’ demand for new or innovative treatments and formats, the OTC market is rapidly expanding.