The purpose of this Association is to guarantee safety, quality and stable supply of imported drugs, and to thus support the drug importation business by its member companies.
The Association operates Registered Laboratories by the Minister of Health, Labour and Welfare, which can be trustfully used by its member companies, in order to guarantee safety and quality of imported drugs. The Association also holds workshops, seminars and briefings concerning the Pharmaceuticals and Medical Devices Law. The following committees are also established.
Discusses general operations of the Association, including its administration and financial affairs, etc., and develops measures required for activities of the Association.
Aiming to improve the precision and speed of testing to meet the needs of members and correspond to the improved level of science, the committees formulate measures to expand and upgrade testing facilities. In addition, the committees are proposing that the laboratories located in Tokyo and Osaka install GMP-compliant facilities, to maintain qualification as testing institutions for registration by the Minister of HLW and as “external testing institutions” of pharmaceuticals.
The committee holds researches and studies on related problems in order to enhance knowledge on the PMDL and regulations and to ensure compliance therewith. It also consults with the relevant authorities and other related organizations as necessary, and then promptly notifies its members of the findings. In cooperation with other committees such as International Affairs and Publicity Committee, ample provision of information is given to overseas manufactures on the Japanese regulations related to APIs. In alliance with the affiliated overseas industry associations, its members also participate in seminars of international exhibitions for dissemination of global regulatory harmonization. Further to such activities, seminars and lectures are also given to the association members in order to promote development and improvement of the level of the industry.
The committee conducts investigations and studies aiming to abolish or reduce tariffs on APIs and intermediates imported by member companies and contributes to the promotion of trade through negotiation with the relevant authorities.
The committee publishes the association’ s activities and information about the government and the industry to its members via the association’ s website constantly and its journals. It plans seminars and workshops together with Legal Committee. It also participates in international exhibitions as well as holds seminars to introduce Japan’s pharmaceutical regulatory systems to foreign manufacturers. In addition, the committee promotes international cooperation with foreign industry associations.
