State Food and Drug Administration: centralized control of the quality of Chinese Herbal Pieces

On August 31, the official website of the State Food and Drug Administration issued the notice on printing and distributing the work plan for the centralized treatment of the quality of Chinese herbal pieces (gyjj [2018] No 28) In recent years, the drug regulatory authorities at all levels have continued to strengthen the supervision and inspection of Chinese herbal pieces, and have investigated and exposed illegal enterprises and unqualified products according to law The overall quality of Chinese herbal pieces has improved, but the existing problems are still not optimistic According to the notice, we will strictly investigate and punish the illegal behaviors in the production and circulation of Chinese herbal pieces, accelerate the improvement of the technical management system in line with the characteristics of Chinese herbal pieces, and strictly control the access standards of Chinese Herbal Pieces production enterprises The following is the full text of the work plan: the work plan for the centralized treatment of the quality of Chinese herbal pieces is an important part of Chinese herbal medicine, which can be used not only in the clinical formula of Chinese medicine, but also in the production of Chinese patent medicine, and its quality is related to the safety and effectiveness of the people's medication In recent years, the drug regulatory authorities at all levels have continued to strengthen the supervision and inspection of Chinese herbal pieces, and have investigated and exposed illegal enterprises and unqualified products according to law The overall quality of Chinese herbal pieces has improved, but the existing problems are still not optimistic In order to further strengthen the supervision and management of Chinese herbal pieces and improve the quality of Chinese herbal pieces, the State Drug Administration has decided to carry out a one-year centralized management of the quality of Chinese Herbal Pieces nationwide The specific plans are as follows: 1 Overall objectives Guided by Xi Jinping's socialist ideology with Chinese characteristics in the new era, we conscientiously implement the nineteen spirit of the party and the four strict requirements of general secretary Xi Jinping on drug safety, adhere to the principle of "problem oriented" and "tackling both the root and the root cause", and strive to solve the outstanding problems existing in China's traditional Chinese medicine pieces, thoroughly investigate hidden dangers in systematic and regional risks, and severely punish illegal behaviors To speed up the establishment and improvement of the long-term mechanism in line with the characteristics of Chinese herbal pieces, improve the regulatory capacity and level, improve the quality of Chinese herbal pieces, and ensure the safety and effectiveness of public medication 2、 Key work (1) strictly investigate and deal with the illegal behaviors of Chinese herbal pieces 1 Strictly investigate and deal with the illegal behaviors in the production of Chinese herbal pieces Strengthen the supervision and inspection of the production link of Chinese herbal pieces, focus on the investigation and treatment of the lax entry control of Chinese herbal pieces, the use of adulterated Chinese herbal pieces to produce Chinese herbal pieces; production of Chinese Herbal Pieces beyond the scope; production capacity and sales volume do not match, make up production and sales records, do not conduct in and out of the factory inspection according to the regulations, and the inspection records are not true; purchase of illegal Chinese Herbal Pieces Such illegal behaviors as changing packaging and selling, renting and lending licenses, subcontracting the production of Chinese herbal pieces to lawbreakers, etc 2 Strictly investigate and deal with the illegal behaviors in the circulation and use of Chinese herbal pieces Strengthen the supervision and inspection of the circulation and use of Chinese herbal pieces, focus on investigating and punishing the conditions such as providing places, qualification certificates and bills for other people's illegal operation of Chinese herbal pieces; do not strictly check the qualification of suppliers, or purchase and sell (or use) Chinese herbal pieces from illegal channels; illegally repackage, process or label the sale of purchased Chinese herbal pieces; operate toxic Chinese Herbal Pieces beyond the scope, etc Violation of laws and regulations 3 Severely investigate and deal with unqualified Chinese herbal pieces We will strengthen the sampling of Chinese herbal pieces, improve the coverage and pertinence of the sampling of Chinese herbal pieces on the market, and focus on such items as adulteration of Chinese herbal pieces, weight gain by dyeing, mildew deterioration, sulfur fumigation, pesticide residues, etc All localities shall, in light of the actual situation of supervision within the administrative region, formulate a sampling plan and increase the frequency of sampling for key regions and key varieties 4 Strictly investigate and punish the illegal production and operation of Chinese herbal pieces We will resolutely ban the illegal dens for the production and operation of Chinese herbal pieces without license, severely crack down on the illegal processing and production of Chinese Herbal Pieces in disguised form, such as illegal cutting and indiscriminate manufacturing, and severely crack down on the illegal elements' operation of Chinese herbal pieces without license （2） Speed up the improvement of the technical management system in line with the characteristics of Chinese herbal pieces 1 Strict access standards for Chinese Herbal Pieces production enterprises, strict verification of the processing scope of Chinese Herbal Pieces enterprises; in accordance with the "technical guidelines for the revision of provincial standards for the processing of Chinese Herbal Pieces" issued by the State Administration, revise the provincial standards for the processing of Chinese herbal pieces 2 Promote the formulation of the processing standards of Chinese herbal pieces; strengthen the registration management of new Chinese herbal medicines, formulate the guiding principles for the quality control research of Chinese herbal medicines, revise and improve the guiding principles for the pretreatment technology of Chinese herbal materials for new Chinese herbal medicine registration; timely formulate, revise and improve the quality standards of Chinese Herbal Pieces in the Chinese Pharmacopoeia, enhance the scientificity and applicability of the standards of Chinese herbal pieces; guarantee the standards of Chinese herbal medicine We should strengthen the information management of TCM reference materials, carry out the research on digital substitution of TCM reference materials, and study and explore the management system of TCM decoction pieces 3 Revise and issue the gap, study and promote the implementation of the gap record management; study and formulate measures to encourage and guide the Chinese herbal medicine enterprises to use the gap base or fixed place of origin for the production of Chinese herbal medicine; combine the characteristics of Chinese herbal medicine pieces and current production practice, revise and improve the GMP Chinese herbal medicine Pieces appendix, enhance the applicability, promote the standardization and specialization of Chinese herbal medicine Pieces enterprises Large scale production 3、 Schedule (I) in the mobilization and deployment stage (August September 2018), each provincial drug regulatory department shall, in accordance with the requirements of this work plan, unify ideas, coordinate actions, combine with local reality, formulate specific implementation plan for remediation work, and submit it to the National Bureau before October 12, 2018 （2） In the organization and implementation stage (October 2018 September 2019), each provincial drug regulatory department shall organize and carry out the quality control of Chinese Herbal Pieces in accordance with this work plan and the specific implementation plan Highlight key issues, urge enterprises to implement the main responsibility, resolutely investigate and deal with violations of laws and regulations; improve the working mechanism and relevant management system, and revise the local processing standards of Chinese herbal pieces Each provincial drug regulatory department shall complete the summary of the rectification work before the end of October 2019 and submit it to the National Bureau The summary of the work shall include the inspection and sampling, the problems found and the treatment, the results achieved and the work suggestions, etc （3） During the period of supervision and summary (September October 2019), the State Administration organized supervision and inspection by means of spot check, praised and rewarded the units and individuals with solid work and outstanding achievements, and investigated and dealt with major cases; criticized and ordered to make corrections if the supervision was not in place, the responsibility was not implemented or the handling of major cases was not in place All localities should conscientiously sort out the rectification work of Chinese herbal pieces, analyze the causes of problems, study solutions, summarize experience and practice, consolidate the results of action, and form a long-term working mechanism for supervision of Chinese herbal pieces 4、 Work requirements (1) strengthen the organization and leadership of the provincial drug regulatory authorities to attach great importance to the rectification action of Chinese herbal pieces, and clarify the work focus and objectives in the specific implementation plan of the rectification work Other departments in charge of drug supervision at all levels shall actively cooperate with the provincial drug supervision departments in carrying out relevant work, practically strengthen organizational leadership, carefully organize and implement, strengthen funding guarantee, unify the organization of competent forces, and carry out targeted remediation work The State Administration will follow up, study and judge the special rectification work, guide and supervise the implementation of laws, regulations and policies, and check the procedures and standards for handling cases （2） Strictly performing their duties, drug regulatory authorities at all levels should improve the pertinence and effectiveness of the rectification work, so as to find out problems, eliminate hidden dangers and prevent risks, and trace the clues found to the bottom In the process of supervision and law enforcement, we should be fair, fair and open, resolutely prevent local protection, and resolutely put an end to the problems of not investigating cases, attaching importance to cases but neglecting them, substituting punishment for custody and substituting punishment for punishment All cases of pleading for enterprises and interfering with the handling of cases in law enforcement shall be recorded and handled in accordance with the law and discipline （3） Strengthen investigation and punishment Drug regulatory authorities at all levels find that the production and operation of Chinese herbal pieces do not meet the requirements of GMP and GSP, and resolutely take measures such as ordering rectification, withdrawing or revoking the certificate of quality management specifications For serious violations of laws and regulations, they firmly order the enterprise to stop production and operation and file a case for investigation, until revoking the drug production license or drug operation license, If a crime is suspected, it shall be transferred to the public security organ to investigate its criminal responsibility For those Chinese herbal pieces that fail to pass the inspection, the source of their products shall be determined to check to the end For illegal acts and unqualified products, the inspection and inspection results shall be disclosed according to laws and regulations We should not only expose the illegal production and operation enterprises of Chinese herbal pieces, but also expose the users of unqualified Chinese herbal pieces In dealing with illegal cases, we should not only punish the illegal production, operation and use units, but also investigate the responsibilities of the persons in charge and other persons directly responsible of the units according to law （4） To strengthen coordination and cooperation in the rectification action, we should strengthen cooperation and cooperation with relevant departments to form a regulatory joint force; give full play to the role of industry associations and experts and scholars, guide industry self-discipline and enterprise integrity; strengthen publicity, accept public and public opinion supervision, and create a good atmosphere for rectification work.