Changes to the European Regulatory Guidelines for the Approval of Antiretroviral Agents
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Drug Information Journal, Vol. 33, pp. 343-345, 1999 Printed in the USA. All rights reserved.
Copyright Q 1999 Drug Information Association Inc.
CHANGES TO THE EUROPEAN REGULATORY GUIDELINES FOR THE APPROVAL OF ANTIRETROVIRAL AGENTS KJELLE. STRANDBERG,MD, PHD Director General, Medical Products Agency, Sweden, and Chairman, CPMP Antiviral Ad Hoc Group
In November 1997, the Committee for Proprietary Medicinal Products (CPMP)amended its points to consider document, which provides licensing criteria for approval of antiretroviral agents, under exceptional and nonexceptional circumstances, in the European Union. The revised guidelines, which are similar to those of the United States Food and Drug Administration, permit the use of short-term plasma HIV-1 RNA data for approval under exceptional circumstances, and data demonstrating the durability of surrogate marker response, consistent with CD4 cell response, for unconditional licensing. These revisions followed a meeting of the Antiviral Ad HOCGroup at which data demonstrating a correlation between reduction in viral load, increase in CD4 cell counts, and clinical benefit were presented. Key Words: Antiretroviral agents; CPMP regulatory requirements; Viral load reduction
INTRODUCTION GUIDELINES FOR THE approval of antiretroviral agents were first developed in Europe in 1995, when the new regulatory system for drug marketing authorization in Europe was introduced, and the new Committee on Proprietary Medicinal Products was instituted. As a result of new data demonstrating that changes in the surrogate marker, HIV-1 RNA, are a strong predictor of clinical benefit (1), these guidelines have recently been changed to include a reduction
Presented at the DIA 34th Annual Meeting ‘Thinking Globally: Product Development, Registration and Marketing in the New Millennium,” June 7-1 l, 1998, Boston, Massachusetts. Reprint address: Professor Kjell Strandberg, m e medelsverket, Box 26. Husargatan 8. S-751 03 Uppsala, Sweden.
in viral load as a criterion for centralized approval of an antiretroviral agent within Europe.
DEVELOPMENT OF CPMP REQUIREMENTS The CPMP is a technical committee, under the European Medicines Evaluation Agency in London, and consists of two members from each member state, drawn from the national regulatory agencies. This committee arrives at scientific positions on, for example, marketing authorization applications (MAA) submissions, safety issues, or arbitration. These opinions then provide the basis for decisions made by the European Commission. The CPMP also has a number of working groups at its disposal, which develop guidance relating, for example, to quality, safety,
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Kjell E. Strandberg
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biotechnology, and efficacy issues. The CPMP can set up task forces when there is a need to establish guidelines, tests, and requirements in a particular area. Specific task forces are also responsible for formulating ‘points to consider’ documents that provide advice on development
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