"Vaccine management law" is about to be implemented, leading enterprises have the opportunity?

[industry trends of pharmaceutical network] on November 18, the State Administration of market supervision and Administration issued a notice on the public solicitation of opinions on the administrative measures for batch issuance of biological products (Revised Draft for comments) According to the notice, in order to establish a scientific and strict vaccine drug supervision and management system and ensure the effective implementation of the vaccine management law to be implemented, the State Drug Administration has organized the drafting of this draft of opinions, which is open to the public for comments and requires feedback before December 17, 2019 The vaccine management law has been deliberated for three times from the proposal of reforming and improving the vaccine management system to the finalization of the draft for comments It was finally voted and adopted at the 11th meeting of the Standing Committee of the 13th National People's Congress on June 29, 2019, and will be formally implemented from December 1, 2019 Vaccine is provided to healthy people, mainly for children and infants Its product quality is directly related to public safety and the happiness of every family Vaccine safety is an organic whole, from the safety and effectiveness evaluation of the registration link, to the quality control verification of the production link, to the reasonable use monitoring of the operation and use link, no matter which link has problems, it will give vaccine safety "a rip out" In order to ensure the quality and safety of vaccines, the state has been strengthening legislation and supervision This time, the measures for the administration of batch issuance of biological products (Revised Draft for comments) was open for comments in order to protect the vaccine management law "Vaccine management law" is evaluated as an extremely strict "the first comprehensive law on vaccines in the world" with 11 chapters and 100 articles in total From the aspects of vaccine development and registration, production and batch issuance, circulation, vaccination, abnormal response monitoring and handling, post marketing management, safeguard measures, supervision and management, legal responsibility, the whole process is vaccine legislation Industry insiders believe that this is the country's centralized response to the "Changchun Changsheng problem vaccine case" which broke out in July 2018, and it is also seen as an opportunity for the vaccine industry to rebuild market trust and move towards reform and innovative development According to the new regulations, vaccines are based on the strict supervision of the whole process, all links and all aspects of the industry, and "encourage the large-scale and intensive production of vaccines", so it is also interpreted by the industry as accelerating the exit of small vaccine manufacturers and promoting industry integration It is reported that the national drug regulatory authorities will be more strict in the audit, inspection and issuance of each batch of products, and experts will be dispatched to the site to verify the safety of each batch of vaccines, and the vaccine regulatory efforts will be increased again With the introduction of vaccine management law, enterprises with poor R & D capacity, small scale, single product, backward technology and lack of technical advantages will face great pressure and may be phased out Compared with other famous pharmaceutical enterprises such as mosadong, Sanofi Pasteur and Pfizer, most of the domestic vaccine enterprises are follow-up innovation with low R & D investment In 2018, the R & D expenses of major vaccine listed companies in China were small, only Watson bio's R & D expenses accounted for more than 10% of the revenue, 14.28%, and Zhifei bio's R & D expenses accounted for only 2.73% of the revenue because it was an agent vaccine product; in addition, the sales expenses of five major vaccine listed companies were large, and the sales expenses of Kangtai bio and Zhifei bio reached the R & D expenses More than five times At present, there are many domestic vaccine manufacturers and fierce competition, while the foreign leading enterprises occupy more than 90% of the market share In the future, the industry resources may be inclined to the vaccine manufacturers with high market share There are also insiders who believe that in the future, the finance may allocate funds to subsidize products that have passed who pre certification, and Chinese vaccine manufacturers are expected to accelerate their entry into the international market But at present, the real challenge for enterprises lies in whether they can continuously improve their technical capabilities, achieve continuous improvement and continuous improvement After all, what people really care about is always the efficacy and safety of vaccines.