The administrative process for medicinal products may be different depending on countries. In Japan, like most countries they are under the control of government. In the case of Japan, the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC) in the National Institute of Health Sciences is now in charge of reviewing process for new pharmaceuticals, which are prepared with the help of earlier consulting activities on clinical trials by the Organization for Pharmaceutical Safety and Research (OPSR). The PMDEC's review is followed by a subsequent decision of the Ministry of Health, Labor, and Welfare (MHLW) to approve or disapprove a product.

The aim is to ensure "timely" patient access to safe, effective and "innovative" medicines and a review system that is consistent from clinical trials to the approval and marketing of pharmaceuticals and medical devices. In the post-marketing phase, a consolidated system will be constituted for collecting (wider range), analyzing, interpreting ADR reaction reports and providing safety information. It is also hoped that "comprehensive" information of "high quality" at international level will be provided to the general public in a "timely" manner in this plan.

In order to accommodate these social demands, based on the "Plan for Consolidation and Rationalization of Public Corporations" decided by the Cabinet in December 2001 followed by the promulgation of the new law in December 2002, PMDEC and OPSR will be unified into the Pharmaceuticals and Medical Devices Agency (PMDA, a tentative name, its official English name has not been decided yet) incorporating some part of duties of a non-profit organization conducting medical device related service supervised by MHLW in April 2004.

According to the current plan, the objective of PMDA is to contribute to public health promotion through the following four operations:

1. Adverse Drug Reaction relief operations: compensate (medical care, pension for the disables, pension for the bereaved) the diseased, injured, families of those who died or those with infections in association with ADR.

2. Review and related operations: provide guidance and advice on clinical trials and approval/review of medicinal products including quasi-drug, cosmetics, and medical devices.

3. Post-marketing safety operations: collect, analyze, and interpret ADR reports and provide safety information on pharmaceuticals and medical devices; also provide guidance and advice to promote safe use of pharmaceuticals and medical devices.

4. R&D promotion operations: basic research for pharmaceutical technologies and promotion of the outcomes.

What is expected of the new organization? It is expected that this initiative will result in smoother and more consistent coordination of consulting and reviewing works related to new pharmaceuticals, since PMDA will conduct clinical trial consultation and New Drug Application (NDA) review by the same review team. Consultation service is expected to expand to medical devices.

Another expectable outcome is the construction of the system to integrate the safety information in the development, approval and post-marketing phase. In addition to above measures, PMDA also plans to increase the staff with relevant expertise for review and postmarketing surveillance operation through which more rapid review can be expected. PMDA is scheduled to adopt a corporate accounting method, and be subject to evaluation on its performance, which will hopefully enable more flexible management.

[Author's Note: The MHLW is preparing details of PMDA, which might differ from what is reported in this article]

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