The state implements a strict access system for vaccine production. To engage in vaccine production activities, it shall be approved by the pharmaceutical supervisory and administrative department of the people's government at or above the provincial level and obtain a pharmaceutical production license.
To engage in vaccine production activities, in addition to the conditions prescribed by law for engaging in drug production activities, the following conditions should also be met: having a moderate scale and sufficient production capacity reserves; Having systems, facilities and equipment to ensure biological safety; Meet the needs of disease prevention and control.
The holder of the vaccine marketing license shall have the vaccine production capacity; If it is really necessary to entrust production beyond the vaccine production capacity, it shall be approved by the pharmaceutical supervisory and administrative department. Those who accept commissioned production shall abide by this law and relevant state regulations to ensure the quality of vaccines.
To apply for batch issuance of vaccines, the batch issuing institution shall provide batch production and inspection records, abstracts and other materials and samples of the same batch of products in accordance with the regulations. Imported vaccines shall also provide certificates of origin and batch issuance. If the origin is exempt from batch issuance, certificates of exemption from batch issuance shall be provided.
Batch issuance of vaccines shall be subject to data review and sampling inspection one by one. The inspection items and frequency of vaccine batch issuance shall be dynamically adjusted according to the risk assessment of vaccine quality.