Issues and Concerns for the Registration of Biological Products in ASIA Pacific: An Introduction to the Session
- PDF / 112,496 Bytes
- 2 Pages / 504 x 720.24 pts Page_size
- 101 Downloads / 209 Views
Drug fnformnrlon loumnl. Vol 31, pp 1383-1384, 1997 Pnnted in the USA All nghu reserved
Copynght 0 1997 Drug Information Associauon Inc
ISSUES AND CONCERNS FOR THE REGISTRATION OF BIOLOGICAL PRODUCTS IN ASIA PACIFIC: AN INTRODUCTION TO THE SESSION IRENEW. WEI, PHD Regulatory Liruson Intemabonal, Merck Research Laboratones, Rahway, New Jersey
INTRODUCTION ASIA IS AN EMERGING market not only for the traditional pharmaceutical industry but also for the biotechnology industry. At least four of the countries in this region will be among the leading economies in the world with annual growth rates of at least 10% (1). With the progressive improvement in the financial wealth of these emerging economies, the desire for biological products is growing. Biotech companies are in turn reflecting greater interest in marketing their products in this region of the world. Global sales of biological products are forecasted by analysts to exceed $20 billion in the year 2000 with around 100 biological products on the market. These products can in total contribute at least half of the new technology for new drugs in the next decade (2). From the viewpoint of the biotechnology industry, the regulatory systems that currently exist in this region of the world are not as transparent as their counterparts in the western hemisphere. Therefore, they may not be as conducive to business expansion and growth. In comparison to the United States Presented at the DIA 32d Annual Meeting 'The Challenge of Worldwide Pharmaceutical Development in an Era of Regulatory Change: Accelerated Approval with Quality and Contained Cost," June 9-13, 1996, San Diego, California. Reprint address: Dr. Irene W. Wei, Associate Director, Merck & Co.. Inc.. P.O.Box 2000, RY33-204, Rahway, NJ 07065-0900.
and the European Union, there appears to be much less regulatory information published and available for use by biotech companies and pharmaceutical companies with biotechnology research and development programs. There also appears to be much less opportunity for dialogue between the industry and the respective regulatory bodies. In recent years the biotechnology industry has experienced increasing interactions with the Center for Biologics Evaluation and Research (CBER) of the United States Food and Drug Administration. During this period, CBER not only reorganized its personnel but also reconsidered its entire review process with the goals of improving efficiency and effectiveness (3,4,5). In light of a need to promote interaction between the biotechnology industry and the regulatory agencies in Asia, a session was organized in the DIA 32ndAnnual Meeting to provide the industry with a regulatory agency overview of the issues and concerns for the registration of biological products in Asia Pacific. Three regulatory agencies, specifically regulatory representatives from Australia, China, and Japan, were invited for the discussion that was intended to stimulate further interactions between the industry and the regulatory agencies in this region. In Asia Pacific, Japan
Data Loading...
