June 7, medical net 

 

Program - text 13 

 

On January 24, 2017, the state council general office issued "on further reform and improve the use policy for producing and distributing medicines of several opinions (countries do hair [2017] no. 13), from the drug research and development production, circulation and use of the whole lifecycle of the request, basically established then the medicine, the development of medical industry in whole tone, policy and regulatory executive direction, it may be said is a programmatic document in the field of medicine. Now, I will tease out the policy hot spots one by one, and discuss the future trends. 

 

The key points of article 13 

 

 

A thorough grooming! Policy hot spots in all sectors 

 

Research and development 

 

New drugs go public 

 

On March 11, 2017 CFDA, issued the decision of adjust the imported drug registration management related matters (draft) ", decided the new drugs will be synchronized global market in China. 

 

1) in China with international multicenter drug clinical trials, cancel the clinical trials should be registered outside the People's Republic of China with medicine or has already entered a stage Ⅱ or Ⅲ clinical trials, vaccine except drugs; 

 

2) for international multicenter clinical trials in China, after completion of the international multicenter clinical drug trial can be directly put forward listing application for registration of pharmaceuticals, 

 

 

 

3) to apply for the import of chemical drugs and drug treatment with biological products innovation, cancellation shall obtain overseas pharmaceutical manufacturers in producing countries or regions listed licensing requirements. 

 

R&d and international integration 

 

On May 11, 2017, the CFDA releases 52? The four "consultation papers", such as 55, laid the foundation for Chinese drug development and international integration. 

 

1) "relevant policies on encouraging the innovation of pharmaceutical medical devices to improve the examination and approval of new drug medical devices" (no. 52, 2017) 

 

A. support for the development of rare diseases and medical devices. The applicant for the treatment of rare diseases and medical devices may offer a waiver of clinical trial application and speed up the examination and approval of medical devices for medical devices for rare diseases. 

 

B. encourage medical institutions to purchase and use new drugs that are clear and reasonably priced. Support for innovative medicines to be included in the coverage of basic medical insurance. 

 

2) the policy on the innovation of innovative clinical trials for drug and medical devices (no. 53, 2017) 

 

3) relevant policies on encouraging the innovation of pharmaceutical medical devices to implement the full life-cycle management of medical devices (no. 54 in 2017) 

 

Conclusion drug marketing authorisation holder pilot experience, combining the revision of the pharmaceutical administration law of the People's Republic of China, the marketing authorisation holder system in the national drug and medical device license (registration) of common practice. 

 

production 

 

Consistency evaluation 

 

1) 2017.03.28, the CFDA issued the guidance on the quality and efficacy of generic drugs (no. 49, 2017) 

 

The conformance evaluation is divided into the following categories: 

 

 

 

2) on May 16, 2017, the CFDA has issued four guidelines for the quality and efficacy of generic drugs 

 

Core: authenticity, consistency, data reliability, and the compliance of the research process. 

 

Consistency evaluates four guidelines for examining key points 

 

 

3) the progress of the conformance evaluation 

 

According to the food and drug verification research institute generics consistency evaluation introduce xiao hong street office, as of May 18, consistency evaluation must be completed by the end of 2018, 289 varieties, 232 varieties have been put on record, varieties did not record the main reasons are: 

 

A) is an old breed in the 12 version of the basic medicine catalogue, and there are not many sales in the market, and the enterprise has low enthusiasm for the small sales. 

 

B) the original medicine was not found; 

 

C) is a special breed in China. 

 

2, regulatory 

 

Since August 2015, the pharmaceutical industry ushered in the four most strict regulation, 2015, 2016, 2016 1 ~ 3 months back your GMP certificate, 147, 170 and 47 respectively, combined with the new drug research and development of provincial (global), consistency evaluation of propulsion and boost capital, also makes the poor strength of mergers and acquisitions of small and medium-sized enterprises, making the number of the national drug substances and drug products manufacturing enterprises declined from 5056 in 2015 to 2015 in November of 4176, data from the year 2016's food and drug regulatory statistical yearbook "). 

 

Number of pharmaceutical companies 

 

 

circulation 

 

two-ticket 

 

The national health and family planning commission (NHFPC) has asked the pilot provinces and regions to make a two-ticket plan by the end of June and by 2018. 

 

As of May 24, 2017, in addition to the 15 provinces released (trial), the three province issued a draft, five drew up the draft (not yet released), 2 provincial forwarding state documents, there are six provinces have not yet post alone, as shown in the table below. 

 

 

 

2, the compliance 

 

The circulation of the "two-ticket system" is intensifying 

 

 

 

2) on May 11, 2017, the CFDA issued "about encouraging drugs medical equipment innovation implementation drugs in whole life cycle of medical instrument management policies" (draft). We started large-scale and large-scale Chinese and western medicine hospitals and hospitals to investigate the action of commercial bribery in pharmaceutical purchase and marketing. The tour cycle: by the end of 2017. 

 

3) on May 12, 2017, the state administration of traditional Chinese medicine (TCM) issued the detailed rules for the inspection of hospitals of Chinese and western medicine and the national medical hospital (2017 edition). 

 

Three bans on medical representatives: 

 

1) to prohibit medical representatives from undertaking drug sales tasks; 

 

2) prohibiting medical representatives from contacting doctors privately; 

 

3) no medical institution shall be allowed to provide the number of prescriptions prescribed by the physician to the medical representative, drug production and operation, etc. 

 

use 

 

On April 19, 2014, seven ministries, including the health and family planning commission (NHFPC), issued a notice on comprehensively opening the comprehensive reform of public hospitals (the national health reform issue (2017) 22). 

 

Demanding "September 30, the abolition of all all public hospital drug addition (except traditional Chinese medicine yinpian). By the end of 2017, four batch of pilot cities before public hospital medicine proportion (excluding Chinese medicine yinpian) to around 30% reduction in overall. 

 

 

 

 

File 1, file 13 

 

The following documents will be released by the end of June, said zhu, the director of the state council health reform office, at the national drug exchange meeting in Shanghai on May 17. 

 

 

 

2, the key task of health reform 

 

In on May 11, 2017, countries who planning department at the conference, the national health and family planning commission TiGaiSi Liang Wannian secretary, said in 2017 in drug supply security and the key work as follows: 

 

 

 

3, the health insurance catalog provincial-level adjustment 

 

On March 18, 2017, people club department Chen Jinfu, director of internal meetings held in chongqing, definitely require the provinces on July 31, 2017 medicare catalog supplement work must be completed and will adjust the quota of people to do the requirements at the same time, the adjustment of the provincial medical insurance directory number control in 291, supplementary limited to class b, and shall not exceed 15% of the number of country b. 

 

On May 8 and May 23, 2017, qinghai and shanxi were the first to issue a consultation draft and a formal health care plan for their health care. 

 

In qinghai and Shanxi Province, the two provincial health insurance plans are different 

 

 

The two provinces of qinghai and Shanxi Province have the same kind of readjustment 

 

 

To extend the concentration of industrial, commercial and circulation industries 

 

The consolidation of the pharmaceutical industry has accelerated the improvement of industry concentration and laid the management foundation for improving the effectiveness, quality and traceability of medicines. 

 

1, the pharmaceutical industry 

 

Ten years, top concentration of pharmaceutical industry increased by 7.4%, from 38.9% in 2005 to 46.3% in the ascent to 2015, but the distance before the European and American three drug companies that account for most of the distance is far to the industry. 

 

 

 

Medical business 

 

Pharmaceutical business concentration improve faster, by 61.6% in 2010 to 68.9% in 2015, five years increased by 7.3%, but from the former three drug firms that accounts for 90% of the distance to the industry further. 

 

 

 

 

Pharmacy chain 

 

Pharmaceutical chain of concentration from 33.8% in 2011 to 34.8% in 2015, is a slow progress, and the former three marketing which accounts for 76% of the whole industry chain (in 2015, IMS data). 

 

 

 

(the author is a vice President of the China chemical pharmaceutical industry association and director of the policy and regulation committee.)