Japan’s MHLW Will Make More Efforts to Combat its Drug Lag Problem

Japan’s Pharmaceutical Manufacturing Association claims that there are about 150 drugs approved in the US and Europe that are not approved in Japan. Obviously, this is to the detriment of Japan’s healthcare system. Of the drugs not available in Japan yet, about 60% are not expected to be developed in Japan any time soon. Many of these drugs are approved for smaller overseas biotech companies as anti-infectives, neurological or gastro products – or could be unique orphan or pediatric products. Given that many overseas companies making these drugs may be concerned about the difficulties and costs of entering the Japanese drug market, the MHLW plans to further encourage Japanese market entry by providing financial support for local Japanese trials, more information on Japan’s regulatory procedures, encouraging Japan’s involvement in global clinical trials and use better public relations to emphasize the benefits of being involved in Japan’s pharmaceutical market.

In addition, and perhaps most strikingly in July, the MHLW promulgated a new plan too – The Council on Unapproved drugs and Indications with Unmet Medical Needs. Under this plan, the Japanese government will take more responsibility for determining the necessity of drugs and drug indications that will benefit Japan. To do this besides the above activities, the Japanese government will begin to make more efforts to contact overseas drug manufacturers with products of high interest. This is a change from the current structure in Japan where only scientific societies and patient groups request access to new medicines for the Council to consider. In short, the Japanese government will now take a lot more active role in getting more overseas new drugs into Japan to help reduce the drug lag.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)