Registration of Biological Products in China
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0092-8615/97 Copyright 0 1997 Drug Information Association Inc.
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REGISTRATION OF BIOLOGICAL PRODUCTS IN CHINA ZHOUHAIJUN Director-General, National Institute for the Control of Pharmaceutical and Biological Products, Ministry of Public Health, The People’s Republic of China, Beijing, China
This paper gives an overall view of biotechnology products in China including drug legislation, classification of new drugs, and registration of biotechnology products. Special attention is given to the issues and concerns in the evaluation of new biotechnology products for approval in China. Key Words: Biological products; Biotechnology products; Biotechnology; Registration in Asia Pacific; China
INTRODUCTION The Pharmaceutical Industry THE TOTAL OUTPUT OF the Chinese pharmaceutical industry has progressively increased by more than 10% annually. The total value of pharmaceutical output in 1995 was approximately $12 billion. With respect to biological products, there are more than 80 different varieties in production; 36 belong to major product classes including 13 viral vaccines, 10 bacterial vaccines, eight blood products, three cytokines, and two toxoid and antitoxin sera products.
DRUG LEGISLATION The Ministry of Public Health is responsible for drug regulation and supervision in China. Under the Ministry of Public Health, there
Presented at the DIA 32“6Annual Meeting “The Challenge of Worldwide Pharmaceutical Development in an Era of Regulatory Change: Accelerated Approval with Quality and Contained Cost,” June %13, 1996, San Diego, California. Reprint address: Professor Zhou H-J., DirectorGeneral, NICPBP. Ministry of Public Health, Temple of Heaven, Beijing 100050, P.R. China.
are several organizations including the Bureau of Drug Management and Policy, the National Institute for the Control of Pharmaceutical and Biological Products, and the Center for Drug Evaluation. “The Drug Administration Act of the People’s Republic of China” went into effect on July 1, 1985; after that the Ministry of Public Health issued the “Provision of New Drug Approval.”
CLASSIFICATION OF NEW DRUGS New drugs are classified into the following categories: Synthetic (modem) drugs, traditional Chinese drugs, and biological products. The biological products are subdivided into four classes according to the nature of the biological product: Class 1: Attenuated and unattenuated live vaccines, 0 Class 2: Dead vaccines, toxoid, antitoxins, specific immuno-globulin, antiserum, mycoplasma, in vivo diagnostic reagents, 0 Class 3: Human plasma derivatives and immunological preparations derived from tissue and plasma with human and animal origin, 0 Class 4: In vivo diagnostic reagents for immunological and serological purposes.
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STATUS OF BIOTECHNOLOGY PRODUCTS The Ministry of Public Health published two guidelines in 1990: “Points to consider for assuring the quality of the products prepared by recombinant DNA
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