News
CFDA strives to improve the level of drug safety supervision
Release time:
2013-05-16 16:46
Source:
On May 13, the fifth annual meeting of the Drug Information Association (DIA) with the theme of "patient care and drug safety" was held in Beijing. Yin Li, deputy director of the State Food and Drug Administration, said at the meeting: "The Chinese government attaches great importance to drug safety and established the State Food and Drug Administration in this institutional reform. The purpose is to optimize regulatory resources and strengthen system risk prevention and control., Comprehensively strengthen food and drug supervision."
Yin Li pointed out that we will reform and improve the drug safety supervision mechanism, scientifically divide the central and local drug supervision powers and responsibilities, content and procedures, and form a supervision system with clear powers and responsibilities, reasonable division of labor, and legal protection; further strengthen the construction of the drug supervision system and continue Improve risk monitoring, standard management, electronic supervision traceability, emergency management and other aspects; actively mobilize social forces to participate in supervision, give better play to the comprehensive power of abnormal mechanism, industry self-discipline and social supervision to promote social co-governance.
The first is to advocate the creation of new drugs and accelerate the reform of drug review. Vigorously promote the construction of drug research platforms, encourage innovative development of new drugs, and strengthen the supervision of drug safety evaluation institutions and clinical trial bases. Intensify the reform of the drug review system, optimize review resources, and improve review efficiency. Carry out quality consistency evaluation of generic drugs to improve the quality of basic drugs and commonly used clinical drugs. Promote the improvement of drug standards and improve the level of drug safety.
The second is to strengthen the construction of drug laws and regulations and drug supervision infrastructure, strictly enforce the law, and administer according to law. Promote the implementation of new GMP and new GSP, and gradually transform the industrial chain into a responsibility chain. We should attach importance to and strengthen drug inspection, reasonably plan the strength and tasks of inspection equipment at the national, provincial and municipal levels, and strengthen the ability of rapid screening at the grass-roots level.
Third, improve the risk early warning and control management mechanism. Strengthen the construction of a strong integrity system, establish a reasonable system to manage people, promote the construction of drug electronic supervision, and gradually realize the real-time monitoring and management of drug quality and flow traceability. Strengthen the capacity building of adverse drug reaction monitoring, and actively carry out post-marketing evaluation of drugs. In view of the key areas and weak links, strengthen the on-the-job training of professional and technical personnel and calendar personnel.
Fourth, crack down on the manufacture and sale of counterfeit drugs to protect the public interest. Special actions will be carried out to crack down on illegal and illegal use of advertising, "black dens" counterfeiting and Internet sales. Build authoritative and convenient drug safety information platform for public inquiry. Strengthen the community-oriented news release and popular science propaganda.
Key words:
Laboratory Equipment
Packaging Equipment
pharmaceutical equipment
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