Medical network, June 13, 2017, Chinese pharmaceutical industry and the road to the global market more quickly than generics consistency evaluation is as loose policy threshold is reduced, increased competition. 

 

Large number of the original transfer property, generics in Europe and the JCP line listed products and a large number of new drugs, synchronizing domestic overseas will be huge impact on the formation domestic generics. 

 

Expired original research medicine: the original research property is changed without the consistency evaluation 

 

On June 9, the CFDA administration has released two consistency about the quality of generic drugs and curative effect evaluation of public announcement of the draft, the industry as the CFDA administration of the signal to adjust policy consistency evaluation - the CFDA administration after the requirements of the consistency of the evaluation policy is too high, leading to domestic enterprises is difficult to carry out the implementation, in order to solve the above difficulties, the CFDA of relevant policies. 

 

Take the example of the adjustment of the pharmaceutical properties of the pharmaceutical products. Reference formulation selection sequence is adjusted for: (a) the original drug: import the original drug, the original enterprise within the territory of China listed drug production, not import the original drugs; In the case of the cessation of production of the original research enterprises, the drug that may be allowed to go public in the United States, Japan or the European Union shall be obtained and obtained the status of the reference. At the same time, "the pharmaceutical that the original research enterprise produces in China" (that is, the original research property product) has been elevated to "original research medicine" status. 

 

The original real estate products in addition to the rising status of consistency evaluation related processes was briefly: if not big change and curative effect with the original quality don't need to carry out consistency evaluation of product quality is no difference. Consistency on the quality of generic drugs and curative effect evaluation of relevant matters announcement will be "about the implementation of the general office of the state council about the opinions of the consistency to carry out the quality of generic drugs and curative effect evaluation > announcement of relevant matters of the original" branded drug property shall carry out consistency evaluation ", is changed to "after the situation according to the classification of treatment: belongs to the public, there was no big change, or after the listed larger changes but does not affect the quality and curative effect after the review, after the food and drug supervision administration audit and verification, can choose for the reference preparation. Belong to the public after a major change and product quality with country of origin effect is different, in this announcement by the enterprise for society issued a statement within 30 days, illustrate the differences and the reasons, and in accordance with the requirements to carry out the consistency evaluation". 

 

The process of the real estate development is brief and short-term positive for the development of the real estate. In the long term, the patent expiration branded products and domestic manufacturer after consistency evaluation of the bidding policy reform, and release a part of the market gave consistency evaluation of domestic manufacturers. 

 

Domestic generic drugs: the cost war is officially launched 

 

The policy of supporting Chinese companies in the European Union, the us or Japan that have been approved for listing in China has accelerated in 2017. As of June 12, 2017, as shown in table 1 with collinear within the territory of a total of 23 to accept order of production and market in Europe and the United States, variety reasons for "quasi" priority review of applications for drug registration ", including a total of 12 accepts the number 2017. 

 

Table 1 is intended to be included in the list of priority reviews 

 

(source: sensitive information) 

 

Shiyao and dongyang light is a "quasi" priority review of applications for drug registration "most products manufacturers, shiyao group, the Italian pharmaceutical co., LTD., the corresponding product with metformin hydrochloride, metformin hydrochloride zyban and clopidogrel bisulfate tablet. In guangdong dongguang pharmaceutical co., LTD., it has the clamycin tablet, the clamycin tablet, and the levofloxacin tablet. 

 

Enterprise production in China in the European Union, the United States or Japan approved but not listed in the territory of China medicine, confirmed by clinical research age-neutral, overseas listing can be used to declare bioequivalence research, pharmaceutical research, data and other technical information to the food and drug supervision administration (center of drug approval) apply for listing; If ethnic differences may exist, corresponding clinical trials should be carried out. This marks the prospect of a direct listing of drugs in the eu, us or Japan that are approved by Chinese companies but are not listed in China. 

 

China has entered the WHO and is interested in joining the ICH, and the next step is likely to be the same as the same policy treatment for the already listed generic drugs in Europe and the us. Or allow domestic manufacturers for Europe and the United States, has listed the manufacturers (not our citizens holding) generic technology licensing, as long as be listed countries recognized origin are collinear dual policy. 

 

For domestic manufacturers, the market for generic drugs is intensifying. On the one hand, there is a high cost of domestic conformity assessment (the total investment of the project over 10 million yuan). On the other hand, the product of domestic co-production and listed on the European and European markets will be the first to compete in this competition. The policy changes of generic drugs will affect the competitive landscape of generic drugs. In any case, cost warfare is the competitive direction of future generics. 

 

Domestic enterprises must begin to calculate a bill, for small and medium-sized enterprise, whether to buy is a risk of third party consistency evaluation project research and development institutions, or their r&d on trial and error to establish their r&d team? Or foreign acquisitions overseas and overseas? Which of these paths is more reasonable and faster? 

 

From market pattern, as long as the profit space is enough, without first copy policy protection for examination and approval of and registration time is reasonable, the future is difficult to a sizeable generics market actual factory number within the three conditions. As long as it is a good product, there will be competition for it. Cost control will be an important requirement for the future of generics firms. 

 

outlook 

 

The value of new drugs will prosper 

 

Policy reforms overall conducive to innovation, the generic competition pattern intensity and market access to overseas will be reversed transmission industry without ready to quickly learn to introduce new drugs, to carry out the first medicine project. I am more puzzled by the fact that, after the market competition is intensified, will the old "me-too" drug still be able to continue to have good performance? 

 

Innovative drugs, especially in domestic research institutions, have low success rates and domestic companies are afraid to invest in them. In pursuit of success and to accept foreign policy once the implementation of data, domestic enterprises will be more actively introduced from overseas mature new drug projects, such as domestic rights and interests of overseas drug buyout is the solution. 

 

The new drug return mechanism overseas is difficult for most small and medium drug companies in the country to take on. The key to assessing the value of a new drug project is the clinical value of the drug, which is often based on the evaluation of data from clinical trials. China has long been engaged in generic drug development and lacks the experience of clinical trials of new drugs. If companies are to establish a new drug system, it will be a big trend to guide overseas Chinese scientists in the short term.