Since its foundation, the Association has supported importation of drugs by its member companies through various activities including management of an inspection and testing facility for quality verification testing of active pharmaceutical ingredients (APIs), etc. of imported drugs. The Association celebrated its 50th anniversary in June 2013.
Quality verification testing of imported drugs at customs was made mandatory by the Pharmaceutical Affairs Law enforced in August 1960. As a result, establishment of a joint inspection and testing facility of APIs that could be used by drug importers was approved by the then Ministry of Health and Welfare on October 30, 1962, in response to a request by the Pharmaceutical Importers’ Group, a private organization of drug importers, constituting the predecessor of this Association. The Japan Pharmaceutical Traders’ Association was later established in June 21, 1963 as the body of drug importers authorized by the Minister of Health and Welfare to manage and administer this inspection and testing facility.
The Association has laboratories in Tokyo and Osaka. Both are intended to be External Pharmaceutical Testing Institutions for its members, as well as Registered Laboratories by the Minister of Health, Labour and Welfare, to which drug manufacturers and marketing authorization holders can outsource their inspection and testing activities. To this end, compliance with the Standards for Inspection and Testing at Pharmaceutical Inspection and Testing Institutions, and with the Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs (GMP), has been ensured through improvement of testing precision and techniques, based on relocation of the Tokyo laboratory to a newly established building in 2009, and expansion of the Osaka laboratory with increased inspection and testing instruments and enhanced testing environment, etc. in 2012.
At the same time, many member companies undertake activities as master file (MF) in-country caretakers and/or registration duties on behalf of foreign manufacturers, etc., besides their drug importation activities. In order to facilitate understanding of Japan’s pharmaceutical regulatory systems required for quality control and stable supply of drugs by foreign manufacturers that export drugs into Japan, the Association also translates information concerning pharmaceutical regulatory administration, etc. into English and Chinese, and distributes the translated information to drug manufacturers in other countries. Other international and publicity activities by the Association include briefings for foreign manufacturers concerning regulatory affairs.
Members of the Association are seeking to contribute to improvement of medical services for Japanese people by continuing to import a wide range of high-quality APIs from around the world, realizing stable supply to marketing authorization holders, and thus ensuring stable provision of drugs required at the point of care.
Today, demand for safety and efficacy of drugs has become larger than ever. The Association is gearing up its systems to guarantee compliance by its members with laws and regulations. The Association also pursues to enhance its members’ abilities to cope with regulatory requirements, through prompt notification of laws and governmental notices, etc., seminars, lectures and other events. Members are determined to proactively cooperate in pharmaceutical regulatory administration activities, toward further development of the pharmaceutical industry.