JPMA's unapproved drug support center for Japan

The Japan Pharmaceutical Manufacturers Association plans to establish an organization, tentatively called the Unapproved Drugs Development  Support Center, in order to back business regarding the  commercialization of drugs not cleared in Japan, including soliciting  potential companies, supporting funds for development and know-how, and  negotiations with the related government agencies. The setting up of the  body will be officially decided at the JPMA's general meeting at  end-April.

Currently, individual drug companies can respond to the development of  compounds that are discussed by the Unapproved Drugs Study Committee  within Japan's Ministry of Health, Labor and Welfare. Henceforth, the  new organization will react to such requests on their behalf.

Resolving the unapproved drugs problem is a requirement of stakeholders  in the process of discussing the introduction of a drug pricing  maintenance special exception system or one for the price of new agents  to be maintained during their patent validity in the plan proposed by  the Federation of Pharmaceutical Manufacturer Associations  (Marketletters passim) within the Chuikyo (the Central Social Insurance  Medical Council). This is because many stakeholders have called on  pharmaceutical firms to improve the situation of unapproved drugs by  making the utmost efforts as the manufacturer side.