Three major agencies responsible for drug and medical device approval in Japan merged into one organization called the Pharmaceuticals and Medical Devices Agency (PMDA), on April 1, 2004. Previously, the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC), Organization of Pharmaceutical Safety and Research (OPSR) and the Japan Association for the Advancement of Medical Equipment (JAAME) were separate organizations, all in charge of the drug and medical device approval process. The creation of the PMDA will consolidate the work of the these three organizations and will make the drug and medical device approval process, including managing consultations for clinical trials, product reviews of approval and licensing applications, and side-effects monitoring, much more timely and efficient in Japan.
Akira Miyajima, the head of OPSR, believes that the new agency will put Japan on the same level as the U.S. FDA and European Agency for the Evaluation of Medicinal Products, approving drugs in an average of 12-16 months. Previously, Japan’s drug approval process could take up to 20 months. By 2009, the PMDA hopes to approve about 80% of drugs within a 12 month period, up from the current rate of 50%.
Additionally, under the PMDA, a fast-track approval process has been initiated for all orphan drugs and devices. Applications for fast-track approval will need to be submitted before any pre-approval consultations can take place and will cost about 751,500 yen (US $6,900). Drugs and devices meeting fast-track criteria – drugs or devices used to treat deadly, life-threatening diseases – will be eligible for this expedited review and approval process.
However, the new agency has a long way to go before it reaches the same approval level as the U.S. and Europe. The agency currently has a shortage of qualified staff and is aiming to boost its staff members from 317 to 357 employees in the next several years. Moreover, it is possible that drug approval fees could double, increasing fees to as much as 16 million yen (US $150,000) per drug. However, analysts say that these higher fees will not hurt a company’s profits, as a drug will be able to hit the pharmaceutical market much sooner with the PMDA’s speedier approval process.