Pharmaceutical Affairs Law (PAL)

Medicinal products in Japan are regulated  by three regulatory statutes - the Pharmaceutical Affairs Law (PAL) and two enforcement regulations :

PAL (Law No. 145 dated August 10, 1960)

(Purpose)

Article 1. The purpose of this Law is to provide regulation required to assure the quality, efficacy and safety of drugs, quasi-drugs, cosmetics and medical devices, and to improve public health and hygiene by taking measures toward promoting the research and development of drugs and medical devices, as particularly important for the medical practice.

Enforcement Ordinance of PAL, PAL-EO (Cabinet Order No. 11 dated January 26, 1961)

Under Japanese legal system the Orders from the Cabinet (Cabinet Orders or Seirei in Japanese) enforce a particular law. The Enforcement Ordinance of PAL has been revised periodically along with the amendments of PAL. The PAL-EO is updated regularly with the latest revision as of July 26, 2006.

Enforcement Regulations of PAL, PAL-ER (MHW Ordinance No. 1, February 1, 1961)

The ordinances from MHLW (MHLW Ministerial Ordinances or Shorei in Japanese) provide detailed guidance on the key issues of the regulated medicinal products. The PAL-EO is updated regularly with the latest revision as of July 26, 2006.

Note: The first two chapters of the Enforcement Regulations of PAL are available as a separate document.

 

Further inquiries should be made by emailing to regulatory@jouhoukoukai.com.