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Chairman of Japan Bulk Pharmaceutical Manufacturers Association
Yutaka Shiratori


Japan Bulk Pharmaceutical Manufacturers Association (JBPMA) is a nationwide association, participated by such member companies who engage in manufacture and sales of bulk and intermediate pharmaceuticals.

This association was originally organized by 25 companies in 1975 for development of the industry of bulk and intermediate pharmaceuticals. As the purpose of this association has awaked a response in the industrial circles concerned, many companies have joined the association year by year, resulting in the increase of the member companies to more than 100 at present.

In the meantime, at the time when the Japanese government implemented new policies such as enactment of Good Manufacturing Practice (GMP) for bulk pharmaceuticals, revision of GMP for pharmaceuticals, and establishment of the criteria for validation, etc. JBPMA lent their cooperation to the authorities and studied compiling relevant explanations and model cases in collaboration with the Federation of Pharmaceutical Manufacturer's Association of Japan.

In recent years, with regard to the International Conference on Harmonization of Technical Requirement of Pharmaceuticals for Human Use (ICH), held by the governments and industries of U.S.A., EU and Japan, JBPMA, together with the Japan Pharmaceutical Manufacturers Association (JPMA), dispatched technical experts to the ICH expert meetings on API GMP (ICH Q7a), as representatives of the relevant industries in Japan, and supported the Japanese government and the industries, thus contributing to the establishment of the ICH guidelines for bulk and intermediate pharmaceutical GMP.

Based the above activities JBPMA has now grown to the organization to represent the nationwide industry of manufacture and sales of bulk and intermediate pharmaceuticals.

Positioning enrichment of GMP in all its aspects as its major objective JBPMA has been active in ensuring the safety and efficacy of pharmaceuticals, guaranteeing product quality, organizing seminars for improving reliance on pharmaceuticals. As for outsourcing issues involving bulk and intermediate pharmaceuticals, where far wider business opportunities are expected in the future, JBPMA intends to make best efforts, jointly with member companies, toward building a framework to grasp such business opportunities in both domestic and foreign countries.

The issue of the primary importance which JBPMA should address is how to cope with the enforcement of the revised Pharmaceutical Affairs Law proclaimed in July 2002. In particular, we intend to set about preparing guidelines for draft ministerial ordinances for GMP, criteria for approval of manufacture and sales (primary pharmaceuticals distributors) and related facilities, the Drug Master File (DMF) system, and inspections to check compliance with GMP requirements.

For the purpose of further prosperity of the industry, this association is trying promoting networking among member companies, thus creating circumstances where technologies, facilities and human resources can effectively be utilized, regardless of scales of member companies, so that they can cope with diversified demands on a global basis.

The home page of this association provides brief outlines of member companies. For further details visitors are requested to refer to their respective home pages.

We heartily hope that this home page helps all viewers understand activities of member companies and this association and extend continued cooperation and supports to member companies and us.



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