Legal basis: Drug Administration Law of People's Republic of China (PRC).
Article 41 To engage in pharmaceutical production activities, the pharmaceutical supervisory and administrative department of the local people's government of the province, autonomous region or municipality directly under the Central Government shall obtain the Pharmaceutical Production License. No drug may be produced without a drug production license.
The Pharmaceutical Production License shall indicate the validity period and production scope, and be re-examined and issued upon expiration.
Article 42 To engage in pharmaceutical production activities, the following conditions shall be met:
(1) Having qualified pharmaceutical technicians, engineering technicians and corresponding skilled workers according to law;
(2) Having a factory building, facilities and sanitary environment suitable for drug production;
(3) Having institutions, personnel and necessary instruments and equipment capable of quality management and quality inspection of the drugs produced;
(4) Having rules and regulations to ensure the quality of drugs, and meeting the requirements of good manufacturing practice formulated by the drug supervision and administration department of the State Council in accordance with this Law.
Article 43 Whoever engages in pharmaceutical production activities shall abide by the good manufacturing practice, establish and improve the quality management system of pharmaceutical production, and ensure that the whole process of pharmaceutical production continuously meets the statutory requirements.
The legal representative and principal responsible person of a pharmaceutical production enterprise shall be fully responsible for the pharmaceutical production activities of the enterprise.