Practical Handbook for Drug Submission and Approval

Author: Dai Shen
Publisher:
Publish Date: 2002-04-01
Features: Excerpt:
1. What are the laws and requirements regarding drug application and approval?
Answer: To strengthen drug management, ensure drug quality, enhance efficacy, and guarantee the safe and effective use of drugs for the health of the people, the state has formulated a series of laws, regulations, and measures. The main laws and requirements related to drug application and approval mainly consist of the following three parts.
(1) National Laws. The Drug Administration Law of the People's Republic of China was passed by the seventh session of the sixth National People's Congress on September 20, 1984, and implemented on July 1, 1985. Article 21 and Article 22 of this law stipulate that clinical trials and production of drugs must be approved by the competent administrative department of the State Council. This law is currently being revised.
(2) Departmental Regulations. Regulations such as the New Drug Approval Measures, the New Biologic Products Approval Measures, the Regulations on New Drug Protection and Technology Transfer, the Approval Measures for Generic Drugs, and the Measures for the Administration of Imported Drugs were implemented by the State Drug Administration (SDA) starting from May 1, 1999. These are important supporting regulations for the Drug Administration Law of the People's Republic of China. At the same time, the SDA has issued or is issuing normative requirements for the entire process of drug research, clinical trials, and production. They include the Good Laboratory Practice (GLP), the Good Clinical Practice (GCP), and the Good Manufacturing Practice (GMP).
(3) Technical Guiding Documents. To assist and guide new drug research units in conducting new drug research and application work in a scientific and standardized manner, the State Drug Administration has organized experts to formulate detailed technical requirements for new drugs, referring to the standards of developed countries and combining with China's actual conditions. Although these are not laws, following these guidelines can yield reliable research results. They are also the basis for the approval of drug review and administration authorities, making them extremely important. Several have been published and implemented in recent years, including:
1. Guiding Principles for Preclinical Pharmacological, Pharmacological, and Toxicological Evaluation of New Drugs (Western Medicine).
2. Guiding Principles for Clinical Research of New Drugs (Western Medicine).
3. Guidelines for Research on New Traditional Chinese Medicine (TCM) Drugs, including guidelines for preclinical pharmacological, pharmacological, and toxicological evaluation of TCM drugs.
2. What are the management agencies for drug review and registration, and what are their main responsibilities?
Answer: The approval and management of drugs are both highly policy-oriented and highly technical. According to Article 21 and Article 22 of the Drug Administration Law of the People's Republic of China and the New Drug Approval Measures, to ensure the safety, efficacy, and controllability of drugs after they enter the market, the state has established management agencies for drug approval and registration. The agencies involved in review and registration work are listed as follows:
(1) Drug Registration Department of the State Drug Administration. Responsible for drafting relevant regulations and implementing them; representing the State Drug Administration to review, assign review tasks, approve, and issue certificates. Address: No. 38, Beilishi Road, Beijing, General Telephone: 68313344, Zip Code: 100810.