The Regulatory Environment for the New Millennium

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 efficacy 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.