NMPA held a working conference on the TCM quality and safety regulation
On December 29, NMPA held a working conference on the TCM quality and safety regulation to comprehensively summarize relevant work in 2021, deeply analyze current regulatory situation and matters, and deploy the priorities in 2022 to continuously enhance the TCM quality and safety regulation. Zhao Junning, Member of NMPA Leading Party Members' Group and NMPA Deputy Commissioner, attended and addressed at the meeting.
In 2021, NMPA thoroughly implemented the decisions and deployments of the CPC Central Committee and the State Council on promoting the inheritance and innovative development of TCM, strictly implemented the Four Strictest requirements, strengthen the TCM quality and safety regulation for epidemic prevention and control, and effectively guarantee the quality and supply of TCM. NMPA continuously improved the development of laws, regulations, institutions and systems for TCM, studied and introduced policies for TCM decoction pieces manufacturers to purchase freshly cut Chinese crude drugs, guided the standardized development of Chinese crude drugs, and accelerated the revision of Good Agricultural Practice (GAP); promoted special rectification of TCM decoction pieces, achieved effective results to be achieved in the special rectification of TCM decoction pieces and the special inspection on TCM production, organized targeted unannounced inspections, and enhance sampling inspections and ADR monitoring. Drug regulatory authorities strictly implemented the territory regulatory responsibilities, strictly investigated and dealt with cases of violation of laws and regulations in the TCM production, urged enterprises to effectively fulfill their principal responsibilities, promoted the successful completion of various objectives and tasks of the supervision over TCM quality and safety regulation, and achieved steady improvement of the overall TCM quality.
Zhao Junning fully affirmed the achievement made in the TCM quality and safety regulation in 2021. He stressed that it is necessary to accurately grasp the new situation, new tasks and new challenges, systematically think, make overall plan, be innovative and responsible, orderly promote the reform of TCM regulatory system, strengthen the TCM quality and safety regulation, and promote the high-quality development of TCM.
The NMPA shall consolidate the TCM quality and safety regulation in 2022. The first is to continuously strengthen the regulation over prepared slices of Chinese crude drugs and TCM preparations for epidemic prevention and control, provide technical guidance and other services, and support TCM to continue to play an important role in regular epidemic prevention and control to safeguard the overall situation of epidemic prevention and control. The second is to accelerate the issuance and implementation of newly revised GAP, orderly promote manufactures of prepared slices of Chinese crude drugs to purchase freshly cut Chinese crude drugs, guide and promote the standardized development of Chinese crude drugs, and promote the TCM quality from the source. The third is to practicably supervise the TCM formula granules, implement strict access for products and enterprises, adhere to the scientificity of TCM formula granules, execute strict regulation over the complete production capacity, prohibit from loosening requirements in a disguised form such as sharing a workshop within the group, carry out the inspection with a full overage of the production and sampling inspection on all varieties, and urge enterprises to ensure product quality and safety. The fourth is to focus on enhancing the supervision over the quality of prepared slices of Chinese crude drugs and TCM preparations, continuously organize special inspections and causal inspections, strengthen sampling inspections and ADR monitoring, strengthen the regulation over the whole chain including production, circulation and use, enhance organic connection between inspections and investigation, and severely crack down on violations of laws and regulations. The fifth is to comprehensively improve the capacity and level of TCM regulation, actively promote the "coordination of nation as in a chess game", vigorously promote the research of TCM regulatory science, actively play the role of "smart regulation", constantly meet the needs of the TCM quality and safety regulation in the new era, and effectively ensure the safety and effective use of drugs by the people.
The meeting was held in the form of videoconferencing. Representatives of 7 provinces (regions) including Anhui, Jiangxi, Gansu, Shandong, Xinjiang, Jiangsu and Guangdong made speeches on the special rectification of prepared slices of Chinese crude drugs, the special inspection on the TCM production and the unannounced inspection on TCM. Leaders of relevant departments as well as directly affiliated institutions of NMPA, leaders of the medical products administration of all provinces (autonomous regions, municipalities) and Xinjiang Production and Construction Corps in charge of the TCM quality and safety regulation, relevant departments and relevant persons in charge of drug inspection institutions participated in the meeting.