After the establishment of the State Food and Drug Administration, it is necessary to burn these five fires
Medical Network April 18th After the establishment of the State Food and Drug Administration, the Secretary of the Secretary for the first time expressed the five major work priorities of the year. Both are closely related to the machinery enterprises.
On April 17, the State Drug Administration convened a cadre conference to thoroughly implement the decision-making arrangements of the Party Central Committee and the State Council, mobilize the deployment of institutional reforms, and study the ideas and initiatives for the development of drug regulatory supervision. Secretary of the Party Committee of the State Drug Administration, Deputy Director Li Li gave a speech, and the director of the State Drug Administration Authority Jiao Hong hosted.
Li Li pointed out at the meeting that he seriously studied and resolved new situations and new issues arising during the reform and development, focused on innovation in supervision methods, improved supervision capabilities, and prevented and controlled security risks. It is necessary to keep the bottom line, strengthen the supervision of the whole process, and step up inspections of hidden safety hazards. Improve emergency handling capacity, strictly prevent strict control of drug safety risks.
For the next phase of the work focus, Jiao Hong arranged from 5 aspects.
The first is to deepen the reform of the review, approval and approval system for pharmaceuticals and medical devices. Regulation The formulation and development of supporting systems will encourage innovative drug and medical devices to enter the market in a timely manner, optimize the review and approval batch process, improve the quality and efficiency of review, and continue to promote the consistency assessment of quality and efficacy of generic drugs.
The second is to strengthen the daily supervision and administration of pharmaceuticals and medical device cosmetics. Continue to adhere to the concept of risk management, persist in problem orientation, strengthen the supervision of high-risk products, strengthen on-site inspection, and effectively compact enterprise The main responsibilities, further strengthen the supervision of random inspections and adverse event monitoring, to prevent strict management and strict control of risk hidden dangers.
The third is to further intensify the crackdown on violations of laws and regulations, strike hard, fight against the code, and crack down on counterfeiting and counterfeiting based on the Internet. The lawmakers continue to maintain a high pressure.
Fourth, we must actively promote 'smart supervision' and 'sunshine supervision' to accelerate the advancement of medicines and medical devices. cosmetic Database construction, vigorously promote the electronic work of administrative licenses, gradually establish a variety of archives, increase the disclosure of government affairs information, regularly publish inspection information such as sampling inspections, penalties, etc. to improve the transparency of supervision.
Fifth, we must strengthen the construction of professional teams. Strengthen the construction of professional reviewers' inspectors. Intensify the systematic training and management of inspectors, expand the career development space for inspectors, and leave professional and technical personnel at the forefront of supervision.
From the above five points, it can be seen that the work of the State Food and Drug Administration formed a good continuity before and after the institutional reform. drug medical instruments As the key reforms in the past few years, review and review and approval reforms will continue to be strengthened; sampling, flight inspections, and routine inspections of the entire process will also be strengthened; and the violators will be dealt with in a high-pressure posture, and heavy blows will be launched, especially in rectification. It is proposed that in order to rectify network sales, under the General Administration of Commerce, it should be able to do more thorough supervision.
It can be said that the supervision will not relax, the machinery enterprises must not relax, and the offenders have serious consequences.
