National Health Insurance Bureau: Requires that the production line of bidding drugs have no violations of GMP in the past 2 years.

On September 20, the National Drug Procurement Office announced the 11th batch of documents for the centralized national organized drug procurement. Regarding the "quality assurance" principle of the 11th batch of centralized procurement, the relevant person in charge of the National Medical Insurance Administration stated that this round of procurement fully solicited and adopted the opinions of the drug regulatory department and the market supervision department. On the basis of ensuring fairness, higher requirements were set for the quality control level of bidding enterprises. First, companies are required to have a certain amount of production experience. Bidding enterprises or their commissioned production enterprises are required to have more than 2 years of production experience in the same dosage form, and the production line of the bidding drug must pass the drug GMP compliance inspection. Second, there are requirements for the inspection of production quality. The previous requirement that the "bidding drug" has not violated GMP in the past 2 years has been expanded to the "production line of the bidding drug" has not violated GMP in the past 2 years. Third, priority is given to clinically recognized and quality-stable companies. When companies have the same bid price, medical institutions that report a higher quantity, or companies that have not made major changes in production processes, active pharmaceutical ingredients, major excipients, etc., are given priority.