Chinese pharmaceutical companies will carry out credit rating evaluation in 2012

The Minister of Health Chen Jie pointed out at the 2012 national food and drug supervision and management meeting held on December 22 that strengthening food and drug supervision and ensuring the quality and safety of food and medicine is the key to deepening medical reform, improving the basic drug system, and promoting the reform of the food and drug regulatory system. task. In 2012, the drug regulatory authorities must conduct evaluations of the credit ratings of pharmaceutical companies, establish corporate integrity records, impose industrial bans on serious violations and untrustworthy persons, and severely crack down on the production and sales of counterfeit and inferior drugs.

Chen Hao pointed out that the State Council executive meeting held on December 7 proposed the overall goal of the drug safety work during the “12th Five-Year Plan” period and required that by 2015, 100% of the drug production meet the requirements of the newly revised “Manufacturing Quality Management Practice” requirements. The level of safety has been greatly improved, and the people's satisfaction with drug safety has increased significantly. To achieve the overall goal of drug safety, the first is to fulfill the responsibility for drug safety in accordance with the requirements of “the overall responsibility of the local government, the regulatory agencies are responsible for each, and the enterprise is the first responsible person”. The second is to strengthen the entire process of quality management of medicines and medical devices. It is necessary to improve drug development standards and promote international standards, increase the coverage of supervision and inspection at the clinical trial sites, establish traceability systems for the circulation of Chinese herbal medicines, promote the standardized production of commonly used Chinese herbal medicines, accelerate the development of regulatory informationization, and implement unified code management for the drugs that have been approved for marketing. Electronic surveillance covers all drug types. The third is to strengthen safety monitoring and early warning. It is necessary to improve the monitoring system of adverse reactions and drug abuse, improve the postmarketing evaluation system for drugs, and focus on strengthening the safety monitoring and evaluation of new drugs, injections of traditional Chinese medicines, and high-risk drugs; and improve emergency response plans to ensure timely and effective supply of emergency drugs. The fourth is to establish a long-term mechanism for the supervision of drug safety. It is necessary to improve the mechanism for the formation of drug prices, centralized procurement policies, and the working mechanism for random inspections of pharmaceuticals, and improve the system for the recall of problem drugs and delisting drugs.

Chen Hao stressed that we must use the basic drug system as the starting point, and monitor the quality of pharmaceuticals as an entry point to ensure that the essential drugs are of reliable quality, reasonable price, timely supply, and safe and effective. Food and drug regulatory authorities at all levels must continue to adopt the "zero-tolerance" attitude, fully implement the "Guidelines for Quality Control of Pharmaceutical Production" revised in 2010, and fully implement electronic supervision of essential drugs. It is necessary to strengthen basic drug sampling and tendering, procurement, and use of quality management, and improve the basic drug supply network and supervision network in rural areas. In particular, it is necessary to strengthen the supply of shortage drugs.

Shao Mingli, secretary of the party group and director of the State Food and Drug Administration, proposed that in 2012, food and drug supervision should focus on perfecting the regulatory system and strengthening the standardization; raising the level of scientific supervision, preventing and controlling food and drug safety risks, and cracking down on violations of laws and regulations. Increase the investigation of cases. It is necessary to continue to crack down on catering services, health foods, and illegally adding cosmetics; maintain a high pressure on counterfeit drugs, strengthen the management of advertisement review, standardize Internet drug trade and information release, and strictly supervise basic drug supervision to ensure quality and safety. Before the end of February 2012, all essential pharmaceutical products produced by all manufacturers must be coded, and all essential drug distribution companies must upload data through the electronic regulatory network. Before the end of February 2013, all types of essential medicines supplemented by various provinces were included in the scope of electronic surveillance.