By "much starker choices-and graver consequences-in" drug safety planning under the state council
Author：中國銘鉉 企劃部 Release Time：2017-2-6 9:13:10 Number Browse：942
Medical network - February 4 February 3, the first working day of the lunar New Year, the state council premier li keqiang chaired a state council executive meeting, adopted "much starker choices-and graver consequences-in" two planning state food and drug safety.
▍ much starker choices-and graver consequences-in
Yesterday publicly planning content mainly refer to three aspects:
One is to strengthen the whole process supervision. To carry out the local county government guarantee food safety responsibility, in particular, on campus, vendors and other key areas and objects of daily supervision, intensify the pesticide veterinary drug residue such as source governance, down on the illegal behavior such as add, beware of systemic risk.
To strengthen the drug clinical trial data authenticity supervision, accelerate the drug production and business operation each link verifiable traceability mechanism construction, crack down on the production and sale of counterfeit goods, fight drug safety incidents.
The second is to strengthen random inspection and risk early warning. Strengthen inspector team professional capacity building, improve the examination system, for all the categories and varieties of food and blood products and vaccines, complete coverage of basic drugs for sampling, improve risk monitoring and evaluation and emergency disposal ability. Build authoritative information release mechanism.
Three is to strengthen technical support. To speed up the national food safety standard system revision, implementing the standard of drugs, medical devices and cosmetics to improve action. Advance pharmaceutical medical device registration review of government purchase service pilot project, has clinical value of innovative medicine and clinical needed drugs introduced priority review for approval.
At the same time, the program emphasizes the use of "Internet +", big data, such as implementing online intelligent supervision, strictly implement the food and drug production, management, use, inspection, supervision and so on each link security responsibility. Let the masses diet medication safety.
▍ speed! Internet +!
Is popular in the market on the concern of the new drug approval, yesterday made clear through the planning, to strengthen oversight of drug clinical trial data authenticity.
Has clinical value in 2016, in order to speed up the urgent clinical needs by new drugs and generic drugs research and development, solve the backlog of drug registration, the state food and drug supervision bureau has issued advice, clear medicine has significant clinical value of innovation, urgent clinical needs, market shortage of drug approval will be priority review.
That time, a total of 17 kinds of drug approval into priority review, including has significant clinical value, has not publicly listed company in China sales of innovation production of medicine and transferred to the territory of China for drug registration; Prevention and treatment of diseases such as AIDS, tuberculosis, viral hepatitis and has significant clinical advantage for drug registration, etc.
This year on January 25th, the scio is further reform and improve the use policy for producing and distributing medicines at the briefing, the several opinions of the national health and family planning commission, deputy director of the Wang Hesheng has said publicly that the next stage of new drugs for examination and approval of the review will be more strict, not only a new drug, country to carry out the consistency for generic drugs already on the market, to strengthen the supervision of the quality of the pharmaceutical production and push backward enterprises exit many measures, such as through measures, ensure the quality of medicines more secure.
At the same time, the planning of Internet + wisdom of drug safety management, can not help but reminiscent of the state council recently canceled Internet medicine for examination and approval of card and card of C B, seems to be let go of the Internet the possibility of the right to sell drugs.
Also in the scio briefing last month, in response to a reporter's question, wu zhen, deputy chief of the state food and drug supervision and administration bureau, said about the Internet + drug circulation, sales policy, are carefully studied. But the drug is a special commodity, special effectiveness in medicine both to speak, also want to security. Drugs should be used under the guidance of a doctor, not their free to buy, free to use, can appear otherwise some adverse consequences even the adr.
Wu pointed out that sell drugs on the Internet, many countries are taking a cautious attitude, is not completely let go. The Internet drug sales policy, both to promote circulation, and to strengthen supervision. If the sales from the regulatory perspective, it may bring harm to public health. "At present, such as B2B, flow to the enterprise by the enterprise, it should be said that the policy is clear, also do not need to worry. We care about is more of B2C, is by the enterprise to the consumers. We emphasis on online sales drugs now online and offline should agree, that is, to carry out online medicine off-line must have the entity shop, so can do their duties, the public rights and interests can be guaranteed."
Although the policy has not been opened, but in the face of the regulatory environment of the Internet, including hebei, heilongjiang, etc more drug safety work throughout the country has to carry out the "Internet + drug regulation" attempt, regulatory "net" when reduced to industry level, seems to be still worth looking forward to.
