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    Home > Active Ingredient News > Drugs Articles > From CFDA! 60 day batch of vaccines

    From CFDA! 60 day batch of vaccines

    • Last Update: 2016-12-19
    • Source: Internet
    • Author: User
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    Source: on December 15, 2016-12-19, the website of State Food and Drug Administration (hereinafter referred to as "CFDA") released the administrative measures for batch issuance of biological products (Revised Draft) (hereinafter referred to as "draft") for comments, with a window of one month This is the second large-scale and long-term consultation on the administrative measures for batch issuance of biological products (Decree No 11 of the Bureau) to be issued in 2004 (December 15, 2015) For the first time, the qualification, responsibility and authority of the "drug control agency" were clarified Sepiland noted that compared with the 2004 version, the draft particularly emphasized the responsibility of the declaration subject of the enterprise - "as the declaration subject of batch issuance, biological products enterprises should perform the legal responsibilities and obligations in the batch issuance activities according to law, and be responsible for the authenticity, integrity and standardization of the batch Issuance declaration materials and samples At the same time, "the Chinese Academy of inspection shall re evaluate other batch issuing agencies every five years", and "for those newly approved to be listed in China, those whose production sites have been changed and approved, and those whose production processes have been changed significantly and approved, at least three batches of products continuously produced after being put into production shall be subject to all project inspections", and other new formulations have also been written into the new regulations As for the time limit issues of general concern to the industry, the draft specifies that "vaccine products should be completed within 60 working days, and blood products and blood source screening reagents products should be completed within 35 working days If retest is required for the inspection, the time limit for batch issuing can extend the two inspection periods of the inspection item and inform the applicant If it is really necessary to extend the time limit for batch issuance due to the variety characteristics and inspection items, the time limit for batch issuance shall be determined and made public after being reviewed by the China Inspection Institute "The concept of" batch issuance "proposed by the World Health Organization is one of the six regulatory functions of drug regulatory agencies in various countries to ensure vaccine quality (the other five are: safety and effectiveness as the evaluation standard, approval process, adverse reaction post market testing, GLP management of product quality control, GMP management of production enterprises Inspection) means that each batch number of products issued in batches must be fully recognized by the national authorities before they are put on the market Because biological products have the characteristics of biological activity, variability, sensitivity to heat and easy to be polluted by microorganisms, the safety and effectiveness of biological products can be guaranteed to the greatest extent only by batch issuing At present, batch issuing has become a mandatory process for biological products including vaccine products, blood products, in vitro diagnostic reagents used for blood source screening, etc before they go on the market in China Inspection and audit is the final security check for such high-risk products In 2013, the hepatitis B vaccine of Shenzhen Kangtai Biological Products Co., Ltd suspected to be related to 7 neonatal deaths was officially confirmed to flow to 27 provinces (regions, municipalities directly under the central government), which triggered a series of chain reactions; in 2015, the 570 million yuan class II illegal vaccine from Shandong flowed into 24 The provincial security incident triggered a series of discussions on the supervision of vaccines and biological products On the other hand, due to historical reasons and realistic objective factors, the drug approval which has been in the state of rush to work is under great pressure In April 2015, Pfizer, the world's largest pharmaceutical company, officially suspended its vaccine business in China due to the expiration of the license According to the information from Pfizer China, "Peier" 13 price combined vaccine as a consideration 2 The vaccination of common pneumococcal diseases for children under the age of five has been on the market in many countries and regions, but it has not completed the process of listing in China However, due to the fact that the time of drug approval in China is generally delayed in other countries, it seems difficult to predict the time to market of the upgraded 13 price vaccine The data shows that the speed of new drug registration and evaluation in China is too slow, the reasons are complex, except for the practical reasons such as the serious shortage of human resources, the sequelae of extensive drugs on the market in the early years has not been fully digested, making the competent authorities cautious about this work According to the public data, in the United States, a new drug approval generally only takes 20 months; in Japan, the average time for new drug approval is 21 months; in the European Union, the approval of new drugs is faster, which takes about a year, while in China, the approval of a new drug may take 2-5 years, a little longer or even 8 years As this problem has become a common problem in the industry, Wu Zhen, deputy director of the drug administration, made a public statement on this issue during the "two sessions" in 2015, and it will take three years to solve the problem of too slow drug approval How to ensure the quality and safety of release at the same time of speeding up, especially for the biological products listed in the high-risk variety management, needs the planning and guidance of new rules.
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