subject: The State Council recently issued a circular: one year time to rectify and standardize market order drugs - drugs market - pharmaceutical industry [print this page] The State Council recently issued a circular: one year time to rectify and standardize market order drugs - drugs market - pharmaceutical industry
7 30, the State Council issued the country to rectify and standardize market order medicines notice of the special action program.
Notice that: the second of Qiqihar in Heilongjiang Province Pharmacy Limited manufacturing and selling counterfeit nature of the case worse, 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 criminal activities of manufacturing and selling counterfeit drugs, drugs to protect people's Security The State Council decided that from now on only use about a year time, in-depth development of a nationwide market order rectification and regulation of pharmaceuticals special action.
In special operations, in the areas of drug research, will focus on combating acts of false declarations, strict review and approval key species, such as chemical injection, Traditional Chinese medicine Injection and the injection of multi-component chemical and biological agent applications for registration of three species, and strengthen the original Accessories Legitimate sources, instructions and Label Content, changing the formulation and increasing the reasonableness of specifications and quality control of generic drug applications and other elements of the technical review; strict Medical Devices Products in the implementation of the national mandatory standards, the Pro Bed Research evaluation and product specifications and other key aspects of approval requirements, cleaning and medical devices are not in default of declaration, examination and approval of the product, and according to law.
In pharmaceutical production areas, mainly for the implementation of a comprehensive GMP inspection. Check will be injection manufacturer in the country 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 management practitioners and corporate responsibility qualification implementation and so on. On the illegal business, according to recover the GMP certificate; circumstances are serious, according to pharmaceutical production license revoked.
Circulation of drugs, mainly the main pharmaceutical business conduct. Strengthen the pharmaceutical business enterprise "Pharmaceutical quality management specification" (GSP) certification track after the inspection, a comprehensive clean-up operation of the main pharmaceutical qualifications, resolutely crack down on drug distributor Rental (by) the permit and approval documents, and drug retailers rent ( use) counter act will severely crack down confusion and purchase channels such illegal purchase and sale records of business activities do not complete. Increase hair Cloth Illegal Advertisement , The masses of quality complaints and a variety of testing hidden strength; strengthen management Vaccine Variety of enterprises and other key regulatory supervision and inspection; to continue treatment "more than one drug," to carry out Pharmaceutical Packaging The label, description of special inspections.
Aspects of drug use, mainly to promote standardized management of medical drugs, regulate prescription and strengthen the publicity of clinical rational use of drugs, Education , Management and supervision, to improve clinical rational medication. Gradually implemented by drugs General Name prescription prescription comment exploration work carried out; implementation of the "clinical application of antibacterial drugs guiding principles" to carry out clinical medicine Monitor To guide the implementation of antimicrobial medical institutions extraordinary amount of dynamic monitoring of early warning, on the behavior of the excessive use of antibiotics in time to intervene. On the chemical injection, traditional Chinese medicine injection, multi-component biochemical injections and vaccines, medical devices and other products adverse events (events) to focus on monitoring and re-evaluation, and timely disposal of group adverse events, as appropriate, to take timely warning, notice, recall and out of other measures.
Clear that this special action to notify Food The main medicines regulatory authorities, relevant departments should closely cooperate to enhance collaboration. Food and drug supervision departments should give full play to their dominant role, the special action to strengthen the guidance and supervision; Development Reform Leather , Health, industry and commerce administration departments to focus on the major task of the special action, conscientiously perform their job responsibilities. Public security organs must root out the making and selling counterfeit and inferior drugs and medical devices criminal networks, and increase manufacturing and selling counterfeit and inferior drugs and medical devices crackdown on criminal activity. Supervision departments should strengthen supervision according to law, refuses to implement national Law Regulations, illegal approval, and selling counterfeit and inferior drugs and medical devices a serious problem areas and departments to strictly pursue the leaders and personnel responsibilities. Propaganda, and propaganda to do relevant work, and create good public opinion environment. [Key words]: Drugs Market Comment Large In Small
