Medical network - March 24, at present our country has built a complete drug supply security system, basically settled the problem of the masses of medicines, drug regulatory system is constantly improving. But the overall level of drug quality remains to be improved, need to continue to strengthen the supply of "life-saving medicine" shortage "medicine", and strengthen supervision and incentive mechanism, improve drug safety and quality
Recently, the state council issued the "much starker choices-and graver consequences-in" national drug safety planning ", to "much starker choices-and graver consequences-in" drug safety work throughout the country as a whole. "Planning" is put forward to strengthen drug development, production, circulation, use link the whole process of supervision, deepening the administrative law enforcement and criminal justice cohesion, push for drug violation penalties to the person's legal measures, intensify efforts to combat illegal and criminal behavior.
"This fully demonstrates the government to crack down on drug violation behavior, maintain the safety of the people use attitude and determination." National school of administration, an associate professor at Hu Yinglian said the drug guarantee system in our country at present stage is in a critical period of transition from safety to the quality, whether in the bottom line on the basis of keep safety to improve the quality of medicines, has become the safeguard public health and enhance supervision efficiency of the main factors.
"Twelfth five-year" period, China's drug safety situation is stable release of a batch of in the treatment of tumor, a rare disease, children's hand, foot and mouth disease, polio, and other fields with independent intellectual property rights of innovative medicine, as well as domestic biological materials, high-end image products, such as heart stents medical device market, greatly satisfy the people's demand.
However, the current our country drug quality security situation is still grim. Overall level of drug quality, part of the product quality effect there is a gap with the international advanced level, some urgent clinical needs products is difficult to meet the actual demand of public cure, nearly three-quarters of unused drug approval number. Based is still relatively weak, at the same time, the drug regulatory oversight capacity is not fully used to with the healthy development of the medicine industry requirements, licensed pharmacists medical service role play does not reach the designated position, the irrational drug use problems still outstanding.
In recent years, the lack of licensed pharmacists has become a big problem in retail drug development. To this, put forward the planning, by 2020, more than 4 per million population number of licensed pharmacists all retail pharmacies main managers qualified licensed pharmacists, the business has licensed pharmacists to guide rational drug use. In addition, for some cheap "life-saving medicine" hard form problem in drug market, "planning" and specifically, to perfect the shortage of drug supply security and early warning mechanism, ensure clinical required, dosage of uncertainty of cheap drugs, rescue medication and rare diseases medicine market supply.
Hu Yinglian said the new target and new concept requires the next stage drug regulatory policy adjusted accordingly to shift from focus on enterprise development to optimize the structure of industry as a whole, from the traditional linear regulatory model to market embedded type regulation means. "Drug regulatory pursue quality, pharmaceutical enterprise in research and development production must pay attention to the dualism of social benefit and economic benefit, not just blindly pursuing economic benefits." Hu Yinglian said.
Social work in the drug safety planning has been improved. "Planning" clear, reasonable division of proper national and local varieties and project, intensify to sample to high-risk varieties, expand coverage for sample; Adhere to the department coordination, the whole chain, break systems and mechanisms affecting the safety of drug quality problems; Formulate detailed drug price, bidding and purchasing, payment, science and technology support and so on supporting policies, establish and improve the incentive mechanism, to urge enterprises actively improve the quality of the product.
, said an official with the national food administration of drug safety related drug safety is public safety, beyond the regulatory safety, can fundamentally solve and resolve the current principal contradiction and diversification of the risk faced by a drug safety. "Planning" for establishing and perfecting the incentive mechanism, and reversed transmission pharmaceutical enterprises from the source, enhance the safety and efficacy of drugs.
"Pharmaceutical industry through the whole chain from the lab to the hospital, and must emphasize collaborative and systematicness of each link policy." Hu Yinglian thinks, on the one hand, to clear drug safety in the health of China's strategic position. In view of the current drug clinical trial is not standard, the pharmaceutical industry structure is not optimal, medicine circulation disorder, the prominent phenomenon of irrational drug use problems, insist on medical treatment, health care, medical reform, linkage around the drug safety "production" "tube" factors such as "this" puts forward targeted measures, from the overall governance highly optimized drug policy system.
On the other hand, will drug regulatory as public security services to provide universal. At the same time, also to promote the pharmaceutical industry supply side structural reforms, because of strong industry with powerful regulation is supported each other.
Also, new drug must be "new", generic drugs must be "with" two big key, encourage research and innovation, improve quality, increase effective supply, ensure drug safety for the people. "Innovation is leading the first motive force in the development and regulation, the pharmaceutical industry must solve clinical problems oriented implement innovation-driven strategy, thus solving structural contradictions." Hu Yinglian said. |
