Global Biotechnology Product Registration: E.U., U.S., and Japan

Within these three "prize" markets, historic and fundamental regulatory changes affecting biotechnology product regulation have been implemented recently. In the United States, the FDA has just implemented a new single license scheme for many of the most important biotechnology products. Within the European Union, biotechnology product developers must now register their therapies through the centralized regulatory procedure administered by the new European Medicines Evaluation Agency (EMEA).

European Union

In 1995, the European Union became the world's single largest pharmaceutical market, and the new European Medicines Evaluation Agency (EMEA) was installed as the regulatory gatekeeper for this market. At that time, the EU also established that the EMEA's new centralized procedure would be mandatory for virtually all significant biopharmaceutical products.

The EU module of Global Biotechnology Product Registration provides a comprehensive and detailed analysis of the European Union's emerging model for biopharmaceutical regulation and approval. And providing this analysis is the Swiss Serum and Vaccine Institute's Head of Worldwide Registration, Regulatory Affairs and Project Management, Mark-M. Struck, Ph.D., who is also a member of the biotechnological and regulatory expert working groups at EFPIA and EVM in Brussels. Dr. Struck is also a member of the Educational Committee of ESRA.

United States

A series of regulatory reforms implemented in 1995 and 1996 will forever change the FDA's regulation of biotechnology products in the United States. While these reforms affected virtually every aspect of biologics regulation in the United States, they had staggering implications for the principles that had been the foundation for biological regulation since the 1940s. Most importantly, for many of the most significant classes of biotechnology products, the FDA dismantled the dual licensing process that had been in place for all biological products for more than half a century.

The U.S. module of Global Biotechnology Product Registration is the first to provide a comprehensive and up-to-date analysis of the post-reform FDA Center for Biologics Evaluation and Research and its new licensing process for therapeutic recombinant DNA-derived products and in vivo monoclonal antibody products. This module covers the complete U.S. biotech product approval process, from preclinical testing to postmarketing regulatory requirements. And because it was written by both CBER officials and industry experts, this module provides readers with perspectives from those who are closest to that process.

Japan

With the number of marketed biopharmaceuticals expected to more than quadruple by the Year 2000, Japan is on the brink of a biotechnology explosion. Despite being one of the world's most lucrative pharmaceutical markets, the Japanese market may be one of the world's least penetrable, due largely to what some view as rigid and poorly defined regulatory requirements and systems for drug and biopharmaceutical product approval.

The Japan module of Global Biotechnology Product Registration presents the first-ever detailed review of Japan's biopharmaceutical approval process from the perspective of a 20+-year veteran of the Japanese drug industry. Hiromi Okabe, Ph.D., who has held clinical, regulatory, and R&D management positions at firms such as Schering Plough, Bristol-Myers, Searle Yakuhin K.K., and Pfizer- Taito Co., Ltd., has worked to develop and implement Japanese regulatory and R&D strategies for a variety of biotech products, including interferon, colony- stimulating factor, interleukins, and monoclonal antibodies.

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