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State Council Issued The “national Rectify And Regulate Drug Market Order The Special Action
Recently, the State Council issued “on the issuance of rectifying and standardizing market order medicines notice of the special action program” (SCS 2006 51).
Rectifying and standardizing market order specific action drugs
Qiqihar in Heilongjiang Province, the company was manufacturing and selling counterfeit nature of the case bad, very bad influence, revealed that China’s pharmaceutical production and circulation order of the outstanding issues, also exposed the work of drug regulatory loopholes. In order to crack down on illegal and criminal activities of manufacturing and selling counterfeit and inferior drugs to protect people’s drug safety, the State Council decided that from now on only use about a year time, in the whole nation is going to rectify and regulate drug market order, the special action.
1, the focus and main objectives
(A) adhere to rectify and standardize the combination of drugs around the development, production, distribution, use four links, highlight the key species and key areas, strict access management, and strengthen routine monitoring, combating crimes, investigate and deal with dereliction of duty, promote self-discipline.
(B) by special action to report fraud and other illegal acts are punished, medicines, medical equipment registered a gradual improvement in order to declare; industry self-regulation has increased the level of “Good Manufacturing Practices” (GMP) are implemented; illegal drug advertisements by regulation, circulation, more standardized business operations; medicines, medical equipment adverse events (events) can be effective monitoring, rational use of drugs to improve the standards, as soon as possible to reverse the field of pharmaceutical production and circulation of supervision and management of confusion, to ensure that drugs regulate production and market quality, used by the people generally enhanced sense of security.
2, the major tasks and work measures
(C) part of pharmaceutical research, primarily against acts of false declarations, strict priority species review and approval.
1. To drugs authenticity and reliability of claims data, medical claims data and clinical studies of authenticity as the main content, to register the applicant to declare acts of checking and correcting themselves, food and drug regulatory departments conduct special inspections and spot checks, fraud investigation and severely behavior.
2. Stringent review and approval injection of chemicals, traditional Chinese medicine injections and injected multi-component chemical and biological agent applications for registration of three species, strengthening the legal sources of raw materials, manuals and labels, change the formulation and increasing the reasonableness of specifications and generic drug applications and other elements of the quality control of the technical review; strict medical device products in the implementation of the national mandatory standards, clinical research evaluation and product specifications and other key aspects of the approval requirements, cleaning and medical devices are not in default of declaration, examination and approval of products, and according to law.
3. Preclinical drug research and development institutions and agencies to conduct a comprehensive clinical trials of drug supervision and inspection of the fraud, management of confusion, can not guarantee that research is true, can not guarantee the safety and rights of subjects, without permission in drug clinical trials, be investigated according to law. Involved in medical institutions, the health administrative department according to law.
(D) in the pharmaceutical production processes, mainly for the implementation of a comprehensive GMP inspection.
1. To injection manufacturer in the National Drug Quality checks have failed record companies and find problems in the follow-up examination in the enterprise and was subjected to inspection of raw materials purchasing, quality inspection, quality practitioners and business intelligence management responsibility for implementation and so on. On the illegal business, according to recover the GMP certificate; circumstances are serious, according to pharmaceutical production license revoked.
2. To have complaints to report, there is potential safety problems, the production company focused on varieties and production control stent, orthopedic fixation devices, products of animal origin medical devices, medical devices companies allogeneic focus on business start-up conditions and quality system compliance check operation. Commissioned the production of medical equipment to conduct a full investigation.
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