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 PHARMACEUTICAL TRADE TALKS FOCUS ON PRODUCT APPROVAL TIME

Executive Summary

U.S.-JAPAN PHARMACEUTICAL TRADE TALKS FOCUS ON PRODUCT APPROVAL TIME and five other issues of interest to the drug and device industry, according to a Commerce Dept. spokesman. The all-day negotiations, which took place Aug. 20 in Hawaii, included discussions on establishment of a time clock like FDA's 180-day regulatory limit for new drug review. Currently, Japan's Ministry of Health & Welfare does not operate under time strictures, although the country has reportedly offered to establish an informal target limit of 365 days. The U.S. delegation is seeking faster approval times particularly for drug and diagnostic test kits designed for in-home use. Mfrs. of such kits reportedly have found it extremely difficult to obtain marketing approval in Japan. The U.S. delegation was headed by the Treasury Asst. Secty. for Internatl. Affairs David Mulford, PhD. The Japanese delegation was led by the Ministry of Health & Welfare's Vice Minister Hitoshi Yoshimura. P Another major topic of trade negotiations for the pharmaceutical industry continues to be the transfer of product approvals from Japanese licensees. Formerly, pharmaceuticals developed by foreign mfrs. had to be licensed to a Japanese firm in order to obtain approval. However, because the Ministry of Health & Welfare issues approvals in a company's name, if a U.S. mfr. now wishes to terminate an earlier marketing agreement with a Japanese firm in order to sell the product there itself, the U.S. mfr. must acquire the Japanese firm's consent. lf the Japanese firm chooses not to transfer the license back to the U.S. mfr., the U.S. firm's only alternative is to'go through the entire regulatory review process in order to obtain marketing approval for the drug under its own name. P The U.S. delegation is also seeking "transparency" in the Japanese govt.'s drug price-setting procedure. Drug prices are set by the govt. in Japan, and U.S. firms would like to participate in the price-setting process. Two other topics discussed in Hawaii are vitamin and health food regulation and the export and re-export of blood products. U.S. industry would like Japan to regulate vitamins and health foods as foods or food supplements, as FDA does. Currently, the Japanese govt. regulates some products as foods and some as drugs.

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

PS008851

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