These Measures shall come into force as of August 5, 2004, and were revised on October 7, 2011. The Measures for the Supervision and Administration of Pharmaceutical Production (for Trial Implementation) issued by the State Administration of Pharmaceutical Products on June 5438+February1KLOC-0/2002 shall be abolished at the same time.
Legal basis: Measures for the Supervision and Administration of Pharmaceutical Production
Article 2 The production, supervision and administration of listed drugs within the territory of People's Republic of China (PRC) shall abide by these Measures.
Article 3 When engaging in pharmaceutical production activities, it shall abide by laws, regulations, rules, standards and norms, and ensure that the information in the whole process is true, accurate, complete and traceable.
Engaged in pharmaceutical production activities shall be approved by the local pharmaceutical supervisory and administrative departments of provinces, autonomous regions and municipalities directly under the Central Government, obtain pharmaceutical production licenses according to law, strictly abide by good manufacturing practice, and ensure that the production process continues to meet the statutory requirements.
The holder of the drug marketing license shall establish a drug quality assurance system, fulfill the responsibility of drug marketing and release, and be responsible for the drug quality of the drug registration certificate obtained by him.
Chinese herbal pieces production enterprises shall fulfill the relevant obligations of drug marketing license holders to ensure that the production process of Chinese herbal pieces continues to meet the statutory requirements.
Raw material drug production enterprises shall organize production according to the approved production process, strictly abide by good production practices, and ensure that the production process continues to meet legal requirements.
Production enterprises that have direct contact with pharmaceutical excipients, packaging materials and containers and other units and individuals engaged in pharmaceutical production activities shall bear corresponding responsibilities according to law.