Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

U.S.-JAPAN DRUG TRADE TALKS: JOINT GMPs FAVORED BY JAPANESE

Executive Summary

U.S.-JAPAN DRUG TRADE TALKS: JOINT GMPs FAVORED BY JAPANESE but U.S. delegation is reluctant to accept the use of "prefectural authorities" to enforce good manufacturing practice regulations (GMPs) in Japan. According to a U.S. government report of a May 9 meeting between U.S. and Japanese government delegations, the Japanese Ministry of Health and Welfare favors a plan under which the two nations would mutually recognize each other's GMPs. The U.S. delegation was concerned, however, about the Japanese government's ability to enforce mutual GMP requirements. The U.S. delegation noted that whereas FDA investigators conduct inspections in the U.S., " prefectural authorities" (local officials) conduct inspections of Japanese drug manufacturing facilities. The May 9 meeting in Tokyo represented the fifth follow-up meeting of the pharmaceutical "MOSS" (market-oriented sector-specific) trade talks. The U.S. delegation included FDA Associate Commissioner for Regulatory Affairs William Schwemer and was led by Commerce Department Deputy Assistant Secretary Maureen Smith. The U.S. delegation was also concerned about an MHW plan to institute "good import practice" regulations, which the U.S. considers "a giant step backward" in the progress Japan has made in simplifying its regulations. The U.S. delegation argued that GIP regulations would be discriminatory, since they apply only to imported medical products. The MHW replied that it is still examining the GIP proposal but is determined to increase its assurance of the quality control of imports, particularly pharmaceuticals and especially those from developing countries. MHW representatives reportedly argued that the GIP plan is not discriminatory but attempts to make requirements for foreign products uniform with Japanese-made products. Japanese companies must comply with Japanese GMPs but foreign companies do not. MHW also noted that FDA sends inspectors to Japan to check for compliance with U.S. GMPs, but MHW does not have the money or the staff to conduct inspections in the U.S. for compliance with Japanese GMPs. The GIP proposal is necessary, the Japanese believe, because MHW cannot inspect in foreign countries as FDA can. Therefore, GIP inspection is needed to check the quality of imports from developing countries without GMPs. The U.S. delegation also complained that Japanese restrictions on the use of hard gelatin capsules for herbal and health foods discriminate in favor of Japanese companies selling those products in soft gelatin capsules. MHW urged the U.S. to consider the restrictions in light of longstanding Japanese buying habits. Because Japanese consumers by custom expect that products in hard gelatin capsules are pharmaceuticals, herbal or health food products encased in hard gelatin capsules could confuse them by giving them the false impression that they are pharmaceuticals, the MHW argued. The U.S. delegation acknowledged the importance of consumer awareness but maintained that consumers can best be informed of product content through package labeling.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

LL1135489

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel