Hebei Province will strengthen pharmaceutical medical device regulatory in 2013
With the continuous development of science and technology, medical equipment, pharmaceutical industry, become two major pillar of the medical field, of course, many cities also the Medical Device regulatory work on the development agenda. It is reported that the Food and Drug Administration in Hebei Province in 2013, will continue to strengthen law enforcement efforts to comprehensively strengthen the supervision of Drugs and Medical Devices, and will continue to improve the public to report complaints system, regulators strive to 360 ° no dead ends.
Strengthen drug clinical trial process supervision
Strengthen drug clinical trial process supervision
Food and drug regulatory departments in our province this year, will continue to organize the supervision and inspection of the implementation of the drug standards and generic drugs consistency evaluation. The intensive medical regulatory and institutional day-to-day supervision of the clinical trial process, the strictly essential drugs as well as high-risk products, Herbal Pieces of Chinese herbal medicines, pharmaceutical excipients regulatory. Steady progress in the new amendments to the Drug Good Manufacturing Practices (GMP) and pharmaceutical quality management specification (GSP) implemented fully completed before the end of the blood products, vaccines and injections of sterile pharmaceutical production enterprise certification of GMP inspections. Continue to promote drug safety demonstration counties. Strengthen pharmaceutical advertising and the Internet Drug Information regulators to crack down on the production and sale of counterfeit and inferior drugs offenses.
In addition, this year the province will improve the 12,331 complaints to report phone network platform to improve food and drug safety prizes complaint reporting system and report complaints to the disposal of the working mechanism, the smooth flow of complaints reporting channels, encourage and mobilize a report from the masses of illegal activities of the Food and Drug. Will be awarded to mobilize the enthusiasm of the masses involved in the food and drug regulatory personnel meritorious. The same time, strengthening the construction of network monitoring system, speed up the establishment of the four products of a mechanical "data centers, to promote the realization of food and drug regulatory information resource sharing and information system platform interoperability, pooling gradually transformed into individual management information system real-time monitoring, integrated management. Approval by the Food and Drug Administration to further improve the integrity management, real-time monitoring, drug electronic inspection reports inspection system platform to promote the national new drugs and sterile drugs electronic monitoring to promote retail pharmacies, and medical institutions to use the terminal to the implementation of electronic monitoring, start drugs production companies direct reporting system construction.
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