National GLP programmes and implication of regulatory authorities for pharmaceuticals, pesticides and other chemicals.
There are various kinds of good laboratory practice (GLP) monitoring authorities (MAs) in the world. Some countries have only one MA, while others, including Japan, have more than one MA. In addition, each MA has its own relationship with regulatory authorities (RAs), receiving authorities (RcAs) and industry based on the internal regulatory systems. There are eight GLP MAs in Japan. This number is probably the largest in the world. Efforts have been made to establish a close link among MAs and to apply and implement GLP programmes in an efficient, effective and consistent way, namely: i) interministerial meeting on GLP. It is essential to establish a system for information exchange and decision making when there are a number of MAs such as in Japan. To this end, the interministerial meeting on GLP has been set up as a means for MAs, RAs, and RcAs to share information on Organization for Economic Co-operation and Development (OECD) and foreign countries and make national decisions as a whole country; ii) joint training programme. With the goal of training inspectors and minimizing differences in inspections among MAs, a joint training programme has been started including joint visits to test facilities (TFs) and participation in evaluation committees at other MAs. One of the purposes of this training programme is to get ready for the on-site evaluation visit (OEV) of the OECD by simulating it at MAs in Japan; iii) joint translation programme of the OECD documents. To avoid unnecessary confusion due to differences of interpretation and translation of OECD documents among MAs, these have been translated into Japanese in cooperation with industry. This has also other substantial merits such as cost reduction and time saving for all stakeholders in Japan. Some countries, both members and non-members of the OECD, have also established more than one GLP MA. It is hoped that the Japanese experience can be useful to them.
Nakashima
Nobumasa
N
Office of Conformity Audit, Pharmaceuticals and Medical Devices Agency, Tokyo-club Building, 3-2-6, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013 Japan. nakashima-nobumasa@mhlw.go.jp
D019411:Clinical Laboratory Techniques / Q000592:standards*; D004467:Economics; D007390:International Agencies; D007564:Japan; D010575:Pesticides / Q000592:standards*; D004364:Pharmaceutical Preparations / Q000592:standards*; D012926:Social Control, Formal
D010575:Pesticides; D004364:Pharmaceutical Preparations