The Regulatory Environment for the New Millennium
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Drug Infomarion h i r n a l , Vol. 34. pp. 659-672. 2000 Printed in the USA. All rights reserved.
THE REGULATORY ENVIRONMENT FOR THE NEW MILLENNIUM STEVENF. HOW, PHD Regulatory Affairs, TAP Pharmaceutical Products Inc., Lake Forest, Illinois
Changes in the global regulatory environment for the pharmaceutical and medical device industries are having a significant impact on how new products are developed and marketed. Throughout the 1990s. major efforts in global harmonization of regulatory requirements were made by several organizations. In the pharmaceutical industry, the many new guidelines for quality, safety, and eflcacy are being implemented in Europe, Japan, and the United States, while work continues to develop the Common Technical Document for the format and content of new market applications. In the medical device industry, the implementation of the European CE Mark and the work of the Global Harmonization Task Force is revolutionizing the regulatory environment. These global efforts along with the national movements to reorganize local regulatory environments in Europe and the United States are discussed. Key Words: Regulatory environment; Harmonization; Global; Drugs; Medical devices
INTRODUCTION DURING THE LAST decade there has been an important evolution in the way the drug and device industries are regulated. These changes have had a significant impact on how new products are developed, manufactured, and marketed. In some cases the rules have become more restrictive, while in others they have become more flexible. Local regulations have seen remarkable changes as the global community has sought to harmonize the process of drug and device development and registration. This has led to the issuance of many new guidance documents and consensus standards through which the industry can more clearly understand the current requirements and processes for new product development and registration. In the past there were many roadblocks
Reprint address: Steven F. Hoff, PhD. Regulatory Affairs, OT-85. TAP Pharmaceutical Products Inc., 675 Field Drive, Lake Forest, IL 60045.
to the rapid development of quality products, with the need to comply with each nation’s regulatory requirements. Duplication of effort and attempted leveraging of various databases for multinational product registrations were often fraught with delay, excessive expenditures, and frustration. This discussion will highlight some of the recent changes in the regulatory areas that significantly impact the pharmaceutical and medical device industries. The focus will be on the recent changes in Europe and the United States, along with the global harmonization efforts.
THE REGULATORY ENVIRONMENT International harmonization of regulatory requirements is having an enormous impact on new product development, manufacturing, and registration. The Global Harmonization Task Force and the European CE Mark are playing an important role in the medical device harmonization process, while the Inter-
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