Yin Li attended the national on-the-spot meeting on the promotion of newly revised drug production quality management standards.


Release time:

2012-12-14

On December 13, the national on-the-spot meeting on the promotion of newly revised drug production quality management standards was held in Taiyuan City, Shanxi Province. The meeting summarized and reviewed the progress made since the implementation of the newly revised GMP and analyzed the current situation. Yin Li, director of the State Food and Drug Administration, stressed at the meeting that it is necessary to strictly control the gate in accordance with the law, adhere to the standard not to be lowered, speed up the implementation of the newly revised drug production quality management standard (hereinafter referred to as the newly revised drug GMP), improve the level of drug quality and safety in China, and promote the transformation and upgrading of the pharmaceutical industry. Wu Zhen, deputy director of the State Food and Drug Administration, presided over the meeting.

Yin Li pointed out at the meeting that it is necessary to thoroughly study and implement the spirit of the 18th CPC National Congress, deeply understand the significance of the implementation of the newly revised drug GMP, emancipate the mind, and improve the relevant policies and measures to support the implementation of the newly revised drug GMP. In the next step of implementation, we should strengthen organizational leadership and form a joint force. Drug regulatory departments of all provinces (autonomous regions and municipalities directly under the Central Government) should take the initiative to strengthen communication and cooperation with development and reform, industry and information technology, and health departments, and establish and improve inter-departmental leading groups or coordination meeting mechanisms. To co-ordinate the national bureau and local bureau of drug GMP certification resources, accelerate the pace of certification. It is necessary to strengthen services and guidance to help enterprises solve practical problems. In the process of work, problems should be found in time, studied and solved. At the same time, it is necessary to strengthen daily supervision, strengthen the implementation of the newly revised drug GMP and the overall improvement of the drug regulatory system to ensure the safety and effectiveness of drugs.

Yin Li stressed that drug regulatory departments at all levels should strictly control the standards in accordance with the law, adhere to the principle that the standards are not lowered, strive to achieve uniform distribution of certification progress, unified grasp of certification standards, and fair and just certification work. All parts of the country have the same standards, the same requirements and the same standards, and the inspection and certification work is not allowed to be lenient and strict, tight before and loose after. Certification and inspection bodies at all levels shall standardize the certification and inspection procedures and strictly enforce the discipline of certification and inspection work. Drug regulatory departments at all levels should make overall plans, combine supervision and implementation of newly revised drug GMP with strengthening daily supervision, ensure that drug production can operate continuously, stably and reliably in accordance with the requirements of drug GMP, be good at finding problems and eliminating hidden dangers from supervision and inspection, transform the drug production supply chain into a quality and safety responsibility chain, resolutely prevent major quality and safety incidents, and comprehensively improve the quality management level of drug production in China.

At the on-site meeting, the person in charge of the Shanxi Food and Drug Administration introduced the bureau's work experience in accelerating the implementation of the newly revised drug GMP. The main responsible persons of the bureaus of 18 provinces (autonomous regions and municipalities directly under the Central Government), including Hebei, Jilin, Jiangxi and Guizhou, exchanged and discussed the progress of the implementation of the newly revised GMP and the next promotion measures.