Medical network May 16 - May 14, 2017, in order to "innovation driven, reconstruct ecology" as the theme of the seven times seven of the President of China pharmaceutical enterprise management association (expand) peak BBS meeting and 31 Chinese medicine industry development was held in Shanghai. During each year as the national drug fair fixed the medicine industry of high-profile events, "peak BBS" gather pharmaceutical industry competent departments, medicine, entrepreneurs, managers, honest, collision wisdom, in a sense, can be regarded as an indicator of industry development. 

 

At the peak on the BBS, from health department, national people club department under the state council, ministry of industry and the CFDA, national ministry of science and technology and other related ministries and commissions of leadership with the top design on the reform of the pharmaceutical industry. One of the most interesting article 13 floor various reform measures, from the latest voice, will be used in pharmaceutical production, circulation, links the three major reform within the scope of a total of 17. What are the reforms? How is it done? They are the hot spots in the industry. 

 

Article 13: by the end of June, there will be detailed local regulations 

 

The outline of the outline of the outline has been put forward, and the concrete policy implementation will be expected. At the end of the speech, zhu yongfeng, director of the state council's health reform office, mentioned in his speech that the implementation details of the implementation of article 13 will be issued by the end of June. In response, various departments will also adopt corresponding management measures. 

 

In particular, the supporting measures of the 13th will be available on drug purchase, drug supply and drug research and development, medicine circulation aspects of specific issues, mainly includes: measures for the management of drugs, clinical bioequivalence trial registration measures for the administration, in the transfer of products to handle way, high value material centralized purchasing pilot guidance, medicine, drug procurement on behalf of the filing management means trust management system, Internet + drug management method as well as improve the generic related policies, etc. 

 

 

 

Rules and supporting the implementation of, but also means about drugs production, circulation, use and so on will have a more specific, and standardize the behavior of the pharmaceutical industry will also be more specific. Taking rational use of medicine as an example, we will carry out the comprehensive evaluation of clinical medicine and make sure that the medicine has the basis and the specification. Hospitals and doctors using drugs will be public, hospital rational drug use to examine the situation will be ranked, and the appraisal results as merit pay for approval. This includes prescribing a prescription from the generic name of the drug and prescribing a prescription for the patient to buy the medicine according to the will. 

 

Upgrading of circulation: the two tickets will not affect the distribution of drugs 

 

There are seven areas of reform that need to be carried out in the field of drug circulation: promoting the transformation and upgrading of drug distribution enterprises; Promoting drug purchase and marketing "two-ticket"; Improve the mechanism for purchasing drugs; To strengthen the management of drug purchase and marketing contracts; To address the outstanding issues in the circulation of pharmaceuticals; Strengthening price information monitoring; Recommended "Internet plus drug circulation". 

 

In the past year, the "two-ticket" system in drug sales has become one of the hottest keywords in the industry. In December 2016, the reform of the state council office issued the public medical institutions in carrying out "two votes" drug purchase implementation opinions (try out) ", announced in 2018 full implementation of two votes horn. In fact, the two votes is drug purchase non-standard constraints of the past, any high-end market-oriented countries require similar controls, also must respond to national policy. 

 

Mr Zhu stressed that the two-ticket system was only a blow to the undisciplined corporate behaviour of the past, and that law-abiding companies would be able to reap the benefits of reform. At the same time, the "two votes" is just two votes, in the field of drug distribution is not in the process of drug transfer distribution two votes, therefore the implementation of the two votes on drug delivery not affected. At the same time, any reform measures may have an impact on some interests and some aspects, but in the direction of big trends and development. From this point of view, it is a good thing that the two-ticket system should improve the industry concentration and improve the orderly development of the industry. 

 

From the point of enterprise transformation and upgrading, encourage enterprises to cross-regional merger and reorganization, cross ownership is a trend, including the integration of drug storage and transportation resources, realize the warehouse together, support cross-regional drug distribution. The government will also help enterprises improve their distribution network and ensure delivery of medicines by improving relevant policies. It also encourages some companies to specialise and switch from distribution to distribution. We will encourage the integration of drug distribution enterprises, promote the classification management of retail pharmacies, and improve the retail chain benefit. 

 

Corresponding to this is to perfect the mechanism of drug purchase, also encourage the cross-regional and specialized subject hospital joint procurement, payment in fully implementing a wave of reform or make medicare drug payment standard, allowing public hospital in the provincial drug centralized purchasing (provincial public resources trading platform) combined with quantity, purchasing budget. We will improve the mechanism for the negotiation of the national drug price, gradually expand the scope of negotiations, and do a good job of connecting with policies such as health care. 

 

It is increasingly clear that drug contract purchase and marketing management will be further strengthened. Yong-feng zhu, the ministry of commerce, the agency, who this year planning department will supervise the drug distribution such as the two sides signed the contract, and in strict accordance with the contract requirements management, drug supply companies to timely delivery, and medical institutions must also be timely collection. "Wool comes out of the sheep", and extended payment time is passed on to drug prices. The better part of this is fujian, where a monthly payment rule makes the cost of corporate capital lower and the price of the drug more reasonable. 

 

At the meeting, a medical representative is mentioned again, a medical representative register records will be built, a medical representative only academic promotion, technical consulting and other activities, shall not be responsible for drug sales, and the faithless behavior recorded in the personal credit record. Drugs in circulation loan business licenses, false trading, falsified records, illegal channels selling drugs, commercial bribery, fraud, price monopoly price and forge or falsely making out and other illegal ACTS related to invoices will be severely hit. 

 

Pharmaceutical production: ensuring supply is the key 

 

Deputy director general of state ministry of industry and consumer goods industry department hai-dong wu said at the meeting, as the country to the attention of the pharmaceutical industry, medical industry of our country is still at a high speed of development. Data from the ministry can strongly suggests that: from the point of growth, in 2016, China's GDP growth of 6.7%, and the pharmaceutical industry's overall growth rate is 10.6%, higher than GDP growth 3.9%; In terms of size, the pharmaceutical industry's revenue was 2.96 trillion yuan in 2016, up 9.92 percent year on year, and the total profit was 332 billion yuan, up from 15.57 percent year on year. It shows that the pharmaceutical industry is growing fast, with good results and high quality. 

 

Even on this basis, however, the supply of high-quality medicines is still one of the most important jobs in the state council 13. Zhu yongfeng said that in the field of pharmaceutical production, we will focus on six areas of reform: the examination and approval of strict drug listing. Accelerating the evaluation of the quality and efficacy of the listed generic drugs; We will carry out trials of the system for the approval of the licensing of drugs to be listed in an orderly manner; To strengthen safety supervision of drug production; We will intensify the restructuring of the pharmaceutical industry. Ensure the effective supply of medicines. 

 

Different drugs have different approaches to the examination and approval of strict drug listing. New drugs focus on clinical value; The generic drugs should be evaluated with the quality and efficacy of the original drug. Drug shortages of new drugs are urgently needed. For rare diseases, children, elderly people, emergency medical treatment and approval of traditional Chinese medicine (TCM), we should draw on international experience. In particular, it is necessary to enforce the compulsory license in accordance with the law when necessary for the prevention of major diseases. At the same time, to do is to enrich review power, strengthen the guidance of enterprise development, establish effective communication with applicants advance mechanism, accelerate the solve the problem of drug registration application backlog. We will strengthen the management of clinical trials, crack down on data fraud, and strengthen the disclosure of information. 

 

In order to accelerate the evaluation of the quality and efficacy of the listed generic drugs, the pharmaceutical manufacturers are encouraged to select the ginseng by the relevant guiding principle. We will accelerate import and approval and improve the efficiency of customs clearance. Consistency at the same time, through evaluation of drugs in clinical use, the respect such as medicare payments to support policies, including through consistency evaluation of drugs into the original drugs are medicines directory, and prior purchasing and use has passed the varieties of consistency evaluation, etc. Yong-feng zhu pointed out that at the same time, still should speed up according to the common name for medicare drug payment standard, form as soon as possible is helpful to the evaluation of consistency with stimulating the use of generic drugs. 

 

In terms of promoting drug marketing authorisation holder system, is "to encourage the new drug research and development" for the purpose, prior approval from the drug trial of new drugs and through the consistency evaluation, early in Beijing and other 10 provinces (municipalities) pilot, and timely sum up experience, strive for an early opened throughout the country. 

 

In strengthening the quality and safety regulation of drug production, the first is to urge enterprises to strictly implement the GMP specification. The number of GMP certificates recovered by drug companies in 2016 and 2017 is increasing rapidly as the CFDA's flight tests become more frequent, with significant regulatory oversight. In the future, the enterprise should make full verification of the changes in the raw materials and the adjustment of production process. 

 

In terms of strengthening medicine industry structure adjustment, support the pharmaceutical production enterprise merger and reorganization, simplified group within the trans-regional transfer formalities for examination and approval of product licensing, guide the resources with brand, technology, characteristics and management advantages of small and medium enterprises in industrial alliance and so on a variety of ways to do better and stronger. It is the ultimate goal of industrial restructuring to make the industry stronger and adjust the backward production capacity. 

 

Finally on the one hand, is to guarantee drug effective supply, which in the present lots of cheap drugs, shortage of life-saving medicine pharmaceutical market environment is particularly significant. Specific measures include designated production, pharmaceutical reserve, emergency production, negotiate, adjust, etc., to ensure drug supply effectively, improve the shortage of drugs, cheap drugs monitoring and warning and hierarchical coping mechanism.