Registration certificate cancellation normalized generic drug companies how to resolve price competition?

September 8, the State Drug Administration issued the Notice on the Cancellation of 78 Drug Registration Certificates for Injection, etc. (No. 96 of 2020). The announcement noted that in accordance with the relevant provisions of the Regulations on the Implementation of the Drug Administration Law of the People's Republic of China and the Measures for the Administration of Drug Registration, the State Drug Administration has decided to cancel 78 drug registration certificates, such as the forefront of injection. The drugs that have cancelled the drug registration certificate are children's aminophen-yellow-sensitive particles, injection of progestin, Malay acid chlorobenzene tablets, cephalosporin particles, cephalosporine particles, amosicillin capsules, isoniazid tablets, silver-yellow particles, hydrochloric acid renitin capsules and other common varieties.

product de-marketing will become the normIn fact, by the end of 2021, the cancellation of drug registration certificates will become the norm, mainly because of policy requirements for consistent evaluation of generic drugs in the National Essential Medicines Directory (2012 edition).On March 5, 2016, the General Office of the State Council's Opinions on the Conduct of a Consistent Evaluation of the Quality and Efficacy of Generic Drugs (State Administration Issued No. 8 of 2016) stipulates that the oral solid preparations of generic generic drugs approved for listing in the National Essential Medicines Catalog (2012 edition) shall be completed by the end of 2018. Among them, clinical effectiveness trials and varieties with special circumstances should be completed by the end of 2021;On May 25, 2016, the former General Administration of Food and Drug Administration issued the Notice on the Implementation of the <>-Related Matters (General Administration of Food and Drug Administration Announcement No. 106 of 2016), and the application for conformity evaluation of the same variety of other pharmaceutical manufacturers will not be accepted after three years after the first one adopts the consistent evaluation of the same varieties of chemicals, except for the generic oral solids prescribed by State Administration No. 8 of 2016.From the State Office issued (2016) No. 8, it can be learned that the 2012 edition of the National Essential Medicines Catalog products, must be completed in 2021 consistency evaluation, otherwise no longer registered. According to China's generic drug consistency evaluation used in the time limit of about one year, such products are still about 15 months from the deadline, if there is no consistency evaluation, sooner or later also have to exit the market. According to General Administration of Food and Drug Administration Announcement No. 106 of 2016, other chemicals imitation oral solid preparations, if the first through a consistent evaluation, registration and acceptance work after three years will also be "automatically closed." Long pain is not as good as short pain, for some small and medium-sized pharmaceutical companies, the existing varieties can not pass a consistent evaluation, the future will inevitably withdraw from the market. Since I can't see hope, why not go in a different direction?

industry chain and the whole marketThe opportunity cost theory shows that resources are limited and will be used in the areas with the highest return on investment. In recent years, the state has implemented a series of policies, such as generic drug consistency evaluation, medical insurance control fees, key monitoring of drug catalogs, volume procurement, crack down on commercial bribery, etc. have changed the market pattern of public medical institutions, the state encourages "drug innovation", "cage for birds", reducing generic drug prices has become the trend, the traditional agency channel model is gradually eliminated, the lack of high price support of generic drugs difficult to survive in the public medical institutions market, domestic generic pharmaceutical enterprises where to go? The integration of raw material preparations and built-in marketing team through 3 channels may be a good choice, at least to resolve some of the risks brought about by price competition.Facts show that domestic generic drug companies that do not attach importance to the construction of research and development and distribution channels have less and less room to survive, and the low profits of generic drug market will become the normal industry, relying on economies of scale advantages may also be able to obtain a certain living space.In order to develop, on the one hand, enterprises must realize the integration of raw material preparations, control costs from the raw material production link, at the same time, pay attention to research and development of high-end generic drugs, establish industry barriers, or achieve the first imitation strategy, access to a rare market opportunity to achieve the competitive advantage of the industrial chain.On the other hand, self-built marketing team, reduce the hospital public medical institutions market lazy, gradually open up the private hospital market, internet and medical markets, online channels and offline retail market, driven by the policy of prescription outflow, these markets growth rate is higher than the public medical institutions market. Only to achieve market-wide coverage, in order to control channels, the future competition of domestic generic drug companies is bound to be the industrial chain and market-wide competition.It can be foreseen that the approval will become scarce resources, multi-species group competition pattern has become the past, pay attention to market research and market segmentation, carefully selected varieties, focus on building heavy varieties, to achieve market segment monopoly, will become the domestic generic drug market competition normal. Merger, reorganization and de-marketing, is the process of resource optimization of the domestic generic pharmaceutical industry, only the size of domestic enterprises is growing, the market concentration is getting higher and higher, the comprehensive strength will be more and more strong, in order to "flash and move", play "imitation combination" or "create imitation combination", or even "global new" and other strategies.According to incomplete statistics, among the A-share and Hong Kong-listed pharmaceutical companies, baiji Shenzhou, Hengrui and Fosun pharmaceutical companies invested a total of nearly 10 billion yuan in research and development; China's generic pharmaceutical industry head pharmaceutical companies rapidly rise to participate in the domestic and foreign markets in the overall competition, but also look at the present. (Medical Economics)