Inventory: who is closely related to our biological, pharmaceutical policy

Medical network - December 4 at the end of 2015, the one month we will usher in a new 2016. This year, the Chinese government issued a lot of biological medicine related policies, ranging from how to apply for new drug approval, to affect the price adjustment of people daily life, is trying. GuJun in this special sorting out of the ten major policy in 2015, and to share with you.

1, the implementation of generic quality consistency and efficacy evaluation opinion (draft)"

Paper includes generic quality consistency and curative effect evaluation, clear the necessity of evaluation object and time limit, determine the reference formulation selection principles, selection of reasonable research methods and so on. Comments: in particular is clear evaluation objects and time limit of this article, on October 1, 2007 approved by the national basic drugs directory (2012 edition) chemicals generics, oral solid preparations should be completed before the end of 2018 the consistency evaluation, which failed to pass the evaluation, the cancellation of drug approval number. That is to say, it's two years from now, during this period, the enterprise need according to original drugs, complete pharmaceutical equivalent type (PE), biological equivalent type (BE), or equivalent type (TE), and other test after treatment to submit the application materials, should still have some of the pressure. The change of the policy what bring industry, still need time to verify.

2, on the authorization of the state council to carry out the pilot drug marketing authorisation holder system and drug registration classification of the pilot reform decision (draft)"

Draft regulations authorized organization of the state council to carry out the drug marketing authorisation holder system pilot, allow drug research and development institutions and scientific research personnel to obtain drug batch number, assume corresponding responsibility of drug quality, at the same time, agree with the organization to carry out the drug registration classification reform of the state council, approved in the production of the national drug standards for drugs, shall meet the national drug standards, and achieve the quality and efficacy of the original drug; Production approval already listed overseas were not listed in the drug, there is no national drug standards, the quality and efficacy of drugs shall meet the original research. Comments: this seems to have a draft issued researchers see the possibility of a rich, in addition to the transfer of technology, also has other way - that is their commissioned medicine production enterprises, the more rewarding. GuJun think this draft is most can stimulate the scientific research institutions and researchers in the recent invention incentive policy. Of course, the return is proportional to the responsibility, have a head to ensure drug quality, rather than the entire enterprise is responsible, more clear responsibility, for drug use and the people is more secure. The practice of drug registration classification pilot can improve the drug quality, promote the transformation and upgrading of Chinese pharmaceutical industry.

3, 2015 edition of pharmacopoeia.

Pharmacopoeia is pharmaceutical industry "constitution", 15 edition pharmacopeia after high-profile. Compared with the former version pharmacopoeia, contains varieties increased 27.4%; The revision of the pharmacopoeia notice, general principles, general overall increase; The appendix (general principles), accessories in separate volumes, constitute the main content of "Chinese pharmacopoeia" four; Varieties of pharmaceutical excipients contains number significantly increased. Comments: whether equipment replacement or personnel training, the promulgation of the new pharmacopoeia puts forward higher requirements on drug firms, and accessories in separate volumes, materials management before not fully on the basis of the phenomenon can be improved. Contains increasing varieties and embodies the pharmacopoeia of advancing with The Times, contribute pharmacopoeia relative to previous page 9, the more close with the international pharmacopoeia standards.

4, 2015, "government work report"

Will "biomass" into the category of "vigorously develop", and "the wind" "light" energy go hand in hand. Comment on: China is a vast land, rich in biomass, although since 7 years "renewable energy development" 11th five-year "plan" put forward, by 2010, China's renewable energy consumption accounts for the proportion of the total energy consumption to 10%, and is expected to reach 15% in 2020, but in fact still slow development of biomass energy industry in China. The biomass of developing into the government work report, it seems to many in the industry is a very exciting signal, signal biomass industry is expected to have strong support from national strategic level, and the rapid development in the near future.

5, "the central committee of the communist party of China to develop the 13th five-year plan for national economic and social development suggestion"

Decided upon by the fifth plenary session of the party's 18, China will adhere to the basic state policy of family planning, improve the population development strategy on the basis of the full implementation of a couple can have two child policy, actively deal with an ageing population. Comment on: 2015 years on the nation's most influential policy must belong to this article, "two children" policy will spill over to the housing, pension, marriage, consumer, medical and other aspects. More than 30 years of the one-child policy in the period, another 20 years, the one-child singleton female's little red book will be the only children to talk about

6, the digital medical equipment focus on specific implementation plan draft"

Aims to promote medical equipment industry in our country, through scientific and technological innovation, independent research and development and technological level, promote transformation and upgrading of industries, cultivating new economic growth point. Comment on: the policy focus has two, one is the digital medical equipment support, POCT industry booming, interrogation made possible the development of telemedicine, promote grading diagnosis and treatment, medical resources distribution, alleviate the pressure of the ordinary medical care in our country. Another key lies in YiXie localization is imperative, for a long time due to technical innovation ability is not strong in China, the combination between production is not tight, YiXie equipment, especially the high-end image diagnosis and large treatment such as digital medical equipment imported. The document, will surely make some domestic medical apparatus and instruments, can borrow their own innovation strength, diversified m&a ideas and advantage of marketing channel of the first to benefit from globalization.

7, "about city public hospital comprehensive reform pilot guidance"

Guidelines mentioned in the reform of public hospitals management system, establish maintenance public welfare, to mobilize enthusiasm and guarantee sustainable public hospital operation mechanism, to break with medicine medical mechanism, reducing drug and medical consumables cost, straighten out the medical service price, and implement the responsibilities for government investment. Comment on: put forward the views, fully embodies the Chinese government to reform the determination, the move touches many ills, hospital income should not only reflected in the use of the equipment, the sale of drugs, should also highlight the doctor service value, and outstanding service value does not mean that the increase of total spending, it means that the hospital benefits of standardization, reasonable means respect for patients and doctors. At the same time, the opinion is pointed out that the future both in public hospitals at the county level and urban public hospitals, will be out of a large number of hospitals allowed to social capital to enter, there is a lot of investment opportunities.

8, "opinion to push forward the reform of drug prices"

Be decided from June 1 this year, in addition to narcotic drugs and the psychotropic drugs of category I, eliminate drug government pricing, improve the mechanism of the drug purchase, give play to the role of health charged fees, drug actual transaction prices are mainly formed by the market competition. Among them, the other medicines turnover stipulated in article 5, by production operators based on the cost of production or operation and market supply and demand situation, independently work out the price. Comments: the so-called government pricing, it is to point to in order to control drug prices in the range of the people can accept, the government to designate the highest retail price of drugs or ex-factory price. Now the government says some drugs won't be the limit, so the drug company seems to be the biggest beneficiary? Actually otherwise, our country most pharmacies sell generic drugs, competition is intense, if the price, must sell. As a result, may appear the phenomenon of lower drug prices. And some of the blood products will raise prices, after all, the cost is right at the moment, at a loss what USES can only lead to high price but eutherapeutic drug died in the market.

9, "stem cell clinical research management approach (trial)"

Management method is put forward for stem-cell research must be level 3 first-class hospital medical institutions, drug clinical trial institution qualification and research conditions, have the ability to risk disposal of stem cell research may encounter. Relevant researchers should also, in the language of popular accurate inform subjects, safeguard the right to know. At the same time, the agency shall not charge stem cell clinical research related to the subjects, shall not release or disguised advertising stem-cell research. Comment on: business industry chain upstream of stem cells is stem cell collection and storage, in this condition can keep synchronization with the world in our country; Middle is stem cell technology research and development, our country the research achievement is substantial; The downstream is stem cell transplantation and treatment, it does indeed seem to not so good. The opinions of the issue, set up a high threshold (level of first-class hospital) open clinical stem cell research, finally take the first step of clinical transformation. Shall not release advertising and fees is specifically for exaggerating stem cells curative effect, the phenomenon of diddle patients, it serves to show the government responsible for stem cell research prudent attitude.

10 and administration of the state food and drug supervision and administration of seeking to speed up the several policy Suggestions to solve the problem of drug registration application backlog of announcement

This announcement involving improve generics approval standard type, specification improvement review for examination and approval of new drugs, allow the applicant voluntarily withdraw does not comply with the conditions of drug registration application, checks on the safety and efficacy of the drug, punishing the clinical trial data frauds, etc comments: 2015 for medicine is doomed to be an extraordinary year, previously the backlog of drug approval, the CFDA is the trend of clear old scores. For new approval, the CFDA raised the threshold for examination and approval, and have to declare to declare, drug firms must carefully, dosage form changing, whether there is enough support data show its advantage; Can choose direction of generic drugs, have enough clinical data shows that with the original drug effect; It'll weigh purse, research and development of new drugs, of course, clinical data verification is a key, the food and drug supervision bureau released about eight enterprises 11 announcement of drug registration applications will not be approved is the best example, clearly tell you that we are serious!