FDA (U.S Food and Drug Administration) is an agency within the Department of Health and Human Services in U.S. It is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, national food supply, cosmetics, and products that emit radiation.Internationally, FDA is considered as one of the biggest food and drug administration agencies. Many other countries are trying to seek for and receiving help from FDA to promote and ensure the safety of their national products.
Among its component departments, Center of Drug Evaluation and Research (CDER) aims at ensuring the safety of prescription drugs and OTC, evaluating new drugs before entering the market, and supervising drugs sold on the market to meet the updating highest standard; Center of Biological Product Evaluation and Research (CBER) is responsible for supervising biological products that can prevent or cure diseases, which is more complicated than general chemical drugs, including the safety and validity on blood, serum, vaccine research, and so on.
More information on FDA:http://www.fda.gov/
GLP (Good Laboratory Practice) is a quality system concerned with the organizational process and the conditions under which non-clinical safety and environmental studies are planned, performed, monitored, recorded, reported and archived. It is the laws and regulations formulated for safety evaluation experiments on medicinal products (both for human and veterinary use), pesticides, industrial chemicals, cosmetics, food- and feed additives and biocides. The main purpose of GLP is to strictly control every sector on chemical safety evaluation experiments, that is, to control a variety of subjective and objective factors that may affect the accuracy of study result for lower experiment errors and the validity of study result. Results of GLP studies are used in connection with notification of clinical trials and application for registration of a new drug/indication.
GLP dates back to seventies of the twenties century. To ensure the validity of study, the American government put forward relative GLP regulations in 1976 which is considered as part of Code of Federal Regulations (CFR). After a serial of revisions, its final regulation number is 21 CFR Part 58.
More details on:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm
The State Food and Drug Administration (SFDA) is directly under the State Council, which is in charge of comprehensive supervision on the safety management of food, health food and cosmetics and is the competent authority of drug regulation.
The SFDA, as the pharmaceutical authority in China, is responsible for supervising the research, production, circulation, and application of drugs, comprehensive superintendence on food, health food and cosmetics, and the approval of healthcare products.
More details on:http://eng.sfda.gov.cn/eng
More Information links:
National Center for Biotechnology Information: http://www.ncbi.nlm.nih.gov/
United States Patent and Trademark Office: http://www.uspto.gov