Premier Wen Jiabao of the State Council presided over the State Council's executive meeting on the 7th to discuss the adoption of the National Drug Safety Plan (2011-2015).
The meeting pointed out that at present, China has formed a relatively complete pharmaceutical production and supply system, and basically established a safety supervision system covering the whole process of drug development, production, circulation and use, and the drug safety situation has been significantly improved, and the drug safety guarantee capability has been significantly improved. However, problems such as the lack of a sound corporate credit system, weak supervisory power, and weak technical support system still exist, and drug safety is still at a high risk. We must adhere to the principle of safety first and scientific supervision, implement drug safety responsibilities, improve the effectiveness of supervision, ensure the quality of drugs, comprehensively improve drug safety guarantee capabilities, and reduce drug safety risks.
The National Drug Safety Plan adopted at the meeting discussed the general objectives and key tasks of drug safety during the 12th Five-Year Plan period. By 2015, 100% of the pharmaceutical production complies with the newly revised "Pharmaceutical Production Quality Management Standard" requirements. The level of drug safety has been greatly improved, and the people's satisfaction with drug safety has increased significantly. The key tasks are:
(I) Raise national standards. Strive for chemical drugs, biological products standards and international standards, Chinese medicine standards leading international standards.
(B) improve the inspection and testing system. We will strengthen the construction of national drug inspection agencies, improve laboratory conditions at the provincial and municipal (prefecture) level, and strengthen the rapid inspection capability of county-level institutions.
(3) Strengthen the overall quality management of medicines and medical devices. Improve drug development standards and promote international integration. Improve the clinical trial site supervision and inspection coverage. Establish a tracing system for the circulation of Chinese herbal medicines to promote the standardized production of commonly used Chinese herbal medicines. Accelerate the supervision of informatization construction, implement uniform code management for the drugs that have been approved for listing, and electronic supervision covers all drug types.
(d) Strengthen safety monitoring and early warning. Improve the monitoring system of adverse reactions and drug abuse, improve the postmarketing evaluation system for drugs, and focus on strengthening the safety monitoring and evaluation of new drugs, Chinese medicine injections, and high-risk drugs. Improve the emergency plan to ensure timely and effective supply of emergency drugs.
(5) Improve the national production and supply capacity of essential medicines to ensure quality, safety and fair access. Strengthen basic drug sampling and tendering, procurement, and use quality management, and improve the basic drug supply network and supervision network in rural areas.
(6) Establish a long-term mechanism for the supervision of drug safety. We will improve the mechanism for the formation of drug prices, centralized procurement policies, and the working mechanism of drug sampling inspections, and improve the system for the recall of problem drugs and delisting drugs. To carry out the assessment of the credit rating of pharmaceutical companies, establish a corporate integrity file, and ban the use of serious violations and untrustworthy persons in the industry. Severely crack down on the production and sales of counterfeit and inferior drugs.
(seven) deepen the reform and improve the legal system. We will deepen the reform of the administrative examination and approval system for pharmaceuticals, tighten standards, and standardize procedures. Innovate the system and mechanism for drug law enforcement and strengthen supervision over law enforcement. Regulate the order of drug circulation and reduce circulation. Accelerate the work on the revision of laws and regulations in drug administration.
The meeting called for fulfilling the responsibility for drug safety in accordance with the general responsibility of the local government, the responsibility of the regulatory authorities and the requirements of the company as the first person responsible, and strengthening departmental collaboration and joint law enforcement. Strengthen publicity and education to increase public awareness of safe drug use and rational drug use. Strengthen talents, science and technology and investment support, promote the adjustment of the pharmaceutical industry structure, and improve the ability of independent innovation.
The meeting also studied other matters.
The meeting pointed out that at present, China has formed a relatively complete pharmaceutical production and supply system, and basically established a safety supervision system covering the whole process of drug development, production, circulation and use, and the drug safety situation has been significantly improved, and the drug safety guarantee capability has been significantly improved. However, problems such as the lack of a sound corporate credit system, weak supervisory power, and weak technical support system still exist, and drug safety is still at a high risk. We must adhere to the principle of safety first and scientific supervision, implement drug safety responsibilities, improve the effectiveness of supervision, ensure the quality of drugs, comprehensively improve drug safety guarantee capabilities, and reduce drug safety risks.
The National Drug Safety Plan adopted at the meeting discussed the general objectives and key tasks of drug safety during the 12th Five-Year Plan period. By 2015, 100% of the pharmaceutical production complies with the newly revised "Pharmaceutical Production Quality Management Standard" requirements. The level of drug safety has been greatly improved, and the people's satisfaction with drug safety has increased significantly. The key tasks are:
(I) Raise national standards. Strive for chemical drugs, biological products standards and international standards, Chinese medicine standards leading international standards.
(B) improve the inspection and testing system. We will strengthen the construction of national drug inspection agencies, improve laboratory conditions at the provincial and municipal (prefecture) level, and strengthen the rapid inspection capability of county-level institutions.
(3) Strengthen the overall quality management of medicines and medical devices. Improve drug development standards and promote international integration. Improve the clinical trial site supervision and inspection coverage. Establish a tracing system for the circulation of Chinese herbal medicines to promote the standardized production of commonly used Chinese herbal medicines. Accelerate the supervision of informatization construction, implement uniform code management for the drugs that have been approved for listing, and electronic supervision covers all drug types.
(d) Strengthen safety monitoring and early warning. Improve the monitoring system of adverse reactions and drug abuse, improve the postmarketing evaluation system for drugs, and focus on strengthening the safety monitoring and evaluation of new drugs, Chinese medicine injections, and high-risk drugs. Improve the emergency plan to ensure timely and effective supply of emergency drugs.
(5) Improve the national production and supply capacity of essential medicines to ensure quality, safety and fair access. Strengthen basic drug sampling and tendering, procurement, and use quality management, and improve the basic drug supply network and supervision network in rural areas.
(6) Establish a long-term mechanism for the supervision of drug safety. We will improve the mechanism for the formation of drug prices, centralized procurement policies, and the working mechanism of drug sampling inspections, and improve the system for the recall of problem drugs and delisting drugs. To carry out the assessment of the credit rating of pharmaceutical companies, establish a corporate integrity file, and ban the use of serious violations and untrustworthy persons in the industry. Severely crack down on the production and sales of counterfeit and inferior drugs.
(seven) deepen the reform and improve the legal system. We will deepen the reform of the administrative examination and approval system for pharmaceuticals, tighten standards, and standardize procedures. Innovate the system and mechanism for drug law enforcement and strengthen supervision over law enforcement. Regulate the order of drug circulation and reduce circulation. Accelerate the work on the revision of laws and regulations in drug administration.
The meeting called for fulfilling the responsibility for drug safety in accordance with the general responsibility of the local government, the responsibility of the regulatory authorities and the requirements of the company as the first person responsible, and strengthening departmental collaboration and joint law enforcement. Strengthen publicity and education to increase public awareness of safe drug use and rational drug use. Strengthen talents, science and technology and investment support, promote the adjustment of the pharmaceutical industry structure, and improve the ability of independent innovation.
The meeting also studied other matters.
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