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

INTERNATIONAL HARMONIZATION: CARCINOGENICITY TESTING AND ADR REPORTS

Executive Summary

INTERNATIONAL HARMONIZATION: CARCINOGENICITY TESTING AND ADR REPORTS are two areas where FDA is hopeful of reaching agreement with EC nations and Japan at the second round of the International Conference on Harmonization (ICH), FDA Policy Development and Coordination Staff Acting Director David Adams told the New York Pharma Forum on Dec. 2. ICH II is scheduled for Oct. 27-29, 1993 in Orlando, Fla. Three working groups on safety, efficacy and product quality were established with representatives from the drug regulatory bodies of the U.S., Japan and European Community during the first round of ICH in Brussels in 1991. Agreements were reached during ICH I in the area of preclinical toxicity studies, which has been published in the U.S. ("The Pink Sheet" April 20, In Brief), and in the areas of stability testing standards and efficacy studies in geriatric populations, Adams noted. "We hope to see significant agreements in ICH II in all three working groups," Adams said. From the safety working group, Adams said FDA is looking for an agreement on carcinogenicity studies, which, he noted, "are expensive and take time and the industry would be well-served by harmonization of these sorts of standards so you don't have to duplicate expensive studies of this type." In the area of safety reporting, Adams said FDA has "high hopes... that we can move towards harmonization of these sorts of reporting systems." Acknowledging FDA's "tentative" early efforts on behalf of international harmonization, Adams characterized ICH "as an anchor for the U.S. involvement" in the harmonization process. He noted that ICH "stands out as one of the few significant harmonization efforts in the history of our government." Initially, Adams said that FDAers found the harmonization process "difficult" given the agency's lack of experience in international standard-making. In addition, Adams pointed out that FDA's harmonization efforts are hampered by legal requirements determined by Congress and by a lack of resources. FDA's ability to share information with foreign governments also is limited by the Freedom of Information laws, he observed. FDA published a proposal to amend FoI to allow the agency to share information with the regulatory bodies of foreign governments in June ("The Pink Sheet" June 29, T&G-8). FDA's internal International Harmonization Task Force has prepared a report outlining the agency's position on harmonization that will be released "in the very near future," Adams announced. Reportedly, the task force report will be released at the Food & Drug Law Institute's annual meeting the week of Dec. 7. Adams said the report will spell out FDA's three harmonization goals: (1) to provide input into international standard setting activities; (2) to accept standards and programs of other countries when they are equivalent to FDA's; and (3) to share scientific information in order to expedite product approvals and to protect the public health. Kazutaka Ichikawa, counselor for Japan's Pharmaceutical Affairs Bureau of the Ministry of Health & Welfare, noted that international harmonization is one of the bureau's top priorities. However, he emphasized that negotiators must approach the process using good science. Ichikawa suggested that a cautious approach to harmonization that does not compromise safety and efficacy standards "is necessary in order to gain the understanding and support of the general public in each of the relevant countries" participating in the harmonization effort.

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

ID1132115

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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