Pharmaceuticals and Medical Devices Evaluation Center

In 1997, the Ministry of Health and Welfare extensively reformed the drug evaluation system and established the Pharmaceuticals and Medical Devices Evaluation Center affiliated with the National Institute of Health Sciences. Under the new system, the Center, through its specialized teams, conducts the evaluation of drugs for which different pharmaceutical companies have sought approval. 

Japan Pharmaceuticals and Medical Devices Evaluation Center (PMDEC)... 

In preparation for this, in April 2004, the Pharmaceutical and Medical Device Evaluation Center (PMDEC), the Japan Association for the Advancement of Medical Equipment (JAAME) and the Organization for Pharmaceutical Safety and Research (OPSR) were merged and integrated in the National Institute of Health Sciences. This... 

An NDA submitted to the MHLW is reviewed by the OPSR. OPSR personnel have the authority to inspect the drug manufacturing facility and clinical trial sites to assess compliance. Results of the review are forwarded to the Pharmaceutical and Medical Devices Evaluation Center (PMDEC), which prepares the approval procedures. The Central Pharmaceutical Affairs Council (CPAC) gives the final approval. Figure 8.10 shows the drug approval process in Japan. 

AppHcations for approval of new drugs and medical devices are referred by PMSB to the Central Pharmaceutical Affairs Council (CPAC) to obtain its recommendation. The CPAC, in turn, is advised by the Pharmaceutical and Medical Devices Evaluation Center (PMDEC), an expert body organized in July 1997 to evaluate the quality, efficacy, and safety of medical products administered to humans. Specific authority within PMSB to approve recommendations received from CPAC regarding the discrete aspects... 

The medical device and pharmaceutical industries have traditionally been separate businesses. The medical device industry generally develops products in line with the EC Medical Device Directive and the guidances issued by the CDRH office of the FDA, whilst the pharmaceutical industry looks to the relevant regulatory guidance available, including that from the FDA Center for Drug Evaluation and Research... 

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