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    Home > Active Ingredient News > Drugs Articles > The State Council has passed the national drug safety plan to prohibit the entry of pharmaceutical enterprises

    The State Council has passed the national drug safety plan to prohibit the entry of pharmaceutical enterprises

    • Last Update: 2011-12-08
    • Source: Internet
    • Author: User
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    Source: Xinhua news agency, 2011-12-08 Premier Wen Jiabao chaired an executive meeting of the State Council yesterday to discuss and approve the national drug safety plan (2011-2015)

    The meeting pointed out that at present, China has formed a relatively complete drug production and supply system, but the integrity system of pharmaceutical enterprises is not perfect, the regulatory power and technical support system are weak and other problems are more prominent, and drug safety is still in a high risk period

    The national drug safety plan adopted at the meeting clarified the overall objectives and key tasks of drug safety during the 12th Five Year Plan period

    By 2015, 100% of drug production will meet the requirements of the newly revised "drug production quality management specification", the level of drug safety will be greatly improved, and the people's satisfaction with drug safety will be significantly improved

    The key tasks are: (1) to improve national standards

    Strive to keep the standards of chemical drugs and biological products in line with the international standards, and the standards of traditional Chinese medicine lead the formulation of international standards

    (2) Improve the inspection and testing system

    We will strengthen the construction of national drug testing institutions and the capacity-building of county-level institutions for rapid testing

    (3) Strengthen the whole process quality management of drugs and medical devices

    Unified coding management shall be implemented for the approved drugs

    (4) Strengthen safety monitoring and early warning

    We will improve the monitoring system for adverse reactions and drug abuse, improve the post market reevaluation system for drugs, and focus on the safety monitoring and evaluation of new drugs, traditional Chinese medicine injections and high-risk drugs

    (5) Improve the production and supply capacity of national essential drugs

    (6) Establish a long-term mechanism for drug safety supervision

    We will improve the mechanism for the formation of drug prices, the policy for centralized procurement and the mechanism for drug sampling, and the recall and disposal system for problematic and delisted drugs

    Carry out the credit rating evaluation of pharmaceutical enterprises, establish enterprise credit files, and prohibit those who seriously violate the rules and lose their credit from entering the industry

    We will severely crack down on the manufacture and sale of counterfeit and substandard drugs in accordance with the law

    (7) We will deepen reform and improve the legal system

    We will deepen the reform of the drug administration examination and approval system

    Standardize the order of drug circulation and reduce circulation links

    We will speed up the revision of drug administration laws and regulations

     
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