Progress and data analysis of the issuance of biological products in 2020

2020 is the year of the construction and improvement of the regulatory system of China's pharmaceutical industry, and many regulations and guidelines have been revised.
, the consolidation of the issuance of biological products induced by the 2018 long-term event has also entered a phase of summary landing.
the end of 2020, the State Drug Administration issued a newly revised Measures for the Administration of the Approval of Biological Products, marking a more standardized phase in the issuance of biological products in China. Part
Part I: A Brief History of the Issue of Biological Products in China A Brief History of the Issue of Biological Products in China, see table below: As can be seen from the table above, the supervision of the issuance of biological products by the Chinese Pharmaceutical Administration has been in place for many years and is becoming more and more standardized.
Part II: Technical Points of the Measures for the Administration of the Approval of Biological Products First. The revised Measures for the Administration of the Administration of the Approval of Biological Products provide more detailed provisions on the duties and powers of various departments For example, article 4 mentions that the State Drug Administration is in charge of the national issuance of biological products, is responsible for defining the scope of the issuance of varieties, designates the issuing authority, specifies the requirements for the issuance of biological products, and guides the implementation of the issuance of biological products.
The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the supervision and management of the applicants for approval in their administrative regions, shall be responsible for organizing on-site inspection of the products approved within the administrative region;
the State Drug Administration designated the issuance authority is responsible for the approval of the issuance, data examination, sample inspection and other work, and in accordance with the law to make the approval decision.
second. For the risks in the production process of biological products to strengthen supervision, whether the product is granted or not requires comprehensive consideration According to the newly revised "Biological Products Approval Management Measures" displayed, in order to implement the Drug Administration Law, vaccine management Law risk management principles, to keep the bottom line of drug quality and safety, "Biological Products Approval Management Measures" to further strengthen risk management measures to ensure the quality and safety of drugs.
is to implement the main responsibility of the enterprise.
enterprises applying for approval must fully evaluate the technical information and product quality before issuing the application, and include this information in the batch issuance information.
is to strengthen supervision and inspection.
provincial drug regulatory departments shall, in accordance with the principles of risk management, supervise and inspect the whole process of issuance, carry out on-site inspection and technical evaluation of the existence of quality risks.
issuer shall carry out the technical examination and sample inspection of the batch issuance in strict accordance with the requirements, and conduct a comprehensive assessment according to the process and quality control maturity of the application for the issuance of varieties and the issuance of previous batch.
should say that this is the most obvious feature of the new regulations.
is to strengthen risk management.
issuing institutions shall, in accordance with the provisions of the issuance process, report in a timely manner the existence of drug quality and safety risks, and make recommendations for risk control.
the major quality risks found by the drug regulatory department in the daily supervision, and promptly inform the issuing authority.
if the inspection reveals that there is a quality risk or safety hazard, the drug supervision and administration department shall take corresponding control measures in accordance with the law, such as responsibility interview, rectification within a time limit, and suspension or non-approval.
control measures after the elimination of risks or rectification, the drug supervision and administration department that takes control measures shall lift the control measures.
fourth is to strengthen accountability.
If the relevant units and personnel fail to make the conclusion of the approval in accordance with the provisions, if the disclosure of work information to the applicant or a third party in violation of the procedural requirements results in serious consequences, or if there is bribery in the process of issuance, and if the on-site inspection is not carried out in accordance with the provisions, the violations and illegal acts shall be dealt with accordingly in a hierarchical manner.
's third. Optimize the process, promote export in order to improve work efficiency, reduce waiting time, so that enterprises as soon as possible high-quality products to serve the community.
17 of the newly revised regulations stipulates that, with the approval of the State Drug Administration, enterprises may apply to the issuing authority for simultaneous issuance after the completion of production.
and, in exceptional cases, grants of exemption may be granted.
, for example, Article 18 stipulates that vaccines that are urgently needed for the prevention and control of infectious disease outbreaks or emergencies shall be exempted from issuance with the approval of the State Drug Administration.
products, whether they are common biological products or vaccines, are in the international market to maintain a certain advantage.
in order to promote the export of products and provide regulatory support for products to occupy the international market, the new regulations improve the relevant requirements.
, for example, Article 45 stipulates that when importing biological products under the administration of approval, the relevant laws and regulations on the import of drugs shall also be complied with.
of biological products approved by the State Drug Administration, the certificate of approval of biological products may be used as a certificate of clearance for the conformity of the products.
vaccines shall meet the standards or contractual requirements of the importing country (region) and may be applied for approval in accordance with the standards of the importing country (region) or the contract requirements.
part III: 2020 data summary and analysis According to the provisions of the State Drug Administration, the current Chinese mainland domestic biological products batch issuance by the Chinese Academy of Sciences and 7 authorized institutions to undertake the issuance of biological products, respectively, Beijing, Shanghai, Guangdong, Sichuan, Hubei, Gansu and Jilin Inspection Institute to jointly promote the issuance of biological products.
of which the batch issuance of vaccines shall be borne by the Central Inspection Court.
According to the batch issuance data published by the china Inspection Court's approval and issuance platform, according to incomplete statistics, about 615 million vaccines will be issued in 2020, an increase of 8.85 percent year-on-year compared with 565 million issues in 2019.
578 million domestically produced vaccines, up 9.47 percent year-on-year, and about 337 million imported vaccines, down 9.76 percent year-on-year.
43 companies applied for vaccine approval in 2020, including 5 importers, including Pfizer Ireland Pharmaceuticals, MSD Ireland, Merck Sharp and Dohme Corp., GlaxoSmithKline Biologicals S.A. and SANOFI PASTEUR S.A., consisting mainly of 10 varieties.
2020, a total of 38 domestic vaccine products were approved for issuance.
Among them, the number of units issued in TOP10 are: Wuhan Institute of Biological Products Co., Ltd., The Institute of Medical Biology of the Chinese Academy of Medical Sciences, Chengdu Institute of Biological Products Co., Ltd., Yuxi Watson Biotechnology Co., Ltd., Beijing Biological Products Research Institute Co., Ltd., Shanghai Institute of Biological Products Co., Ltd., Amy Hanxin Vaccine (Dalian) Co., Ltd., Liaoning Chengda Biological Co., Ltd., Lanzhou Institute of Biological Products Co., Ltd., Hualan Biomass Vaccine Co., Ltd.
The figure below introduces the specific data and ranking of top10 enterprises issuing: Figure 1 2020 vaccine batch issuance quantity TOP10 enterprise analysis: From the above chart data can be seen, in vaccine production, research and development and batch issuance work, Wuhan Biological Products Institute is unique, in terms of scientific research strength and production capacity are in a leading position.
also shows that traditional biological products excellent units continue to maintain a leading position in the industry.
, Yunnan Watson Bio's batch issuance data ranked fourth in the country, but also achieved good results.
as an excellent biopharmaceutical company located in the southwest, Yunnan Watson Bio has been continuously strengthened in terms of production workshop, batch number and industrial layout.
, despite the volatility of the shift in core assets at the end of 2020, has generally been stable.
from top10 data, China's biological products in the geographical advantage of the situation is stable, there will be no major changes in the near future.
if there is a possibility of a breakthrough, it is predicted that Shanghai because in recent years there are many innovative biological products enterprise products are about to go offline, will have an impact on the layout of the industry.
All in all, we believe that the pharmaceutical industry, which will contribute to China's fight against the disease in 2020, will continue to play an advantageous role in 2021, and that more vaccines to fight the new coronavirus will be approved and put into use.
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