echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Medical World News > 2017-2019 SFDA's inspection of overseas pharmaceutical enterprises

    2017-2019 SFDA's inspection of overseas pharmaceutical enterprises

    • Last Update: 2020-01-16
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Text: zulikou431 As the leading pharmaceutical market in the world in terms of total volume, Chinese pharmaceutical market has always been concerned by overseas pharmaceutical enterprises The supervision and inspection of overseas enterprises is also one of the key work of SFDA The inspection of overseas pharmaceutical enterprises launched in 2012 is a start; with the improvement of the laws and regulations of the State Administration and the strengthening of the construction of technical force, from 2015, the frequency and strength of the inspection of overseas pharmaceutical enterprises by the State Administration has been continuously strengthened This paper summarizes the inspection data and information of 2017-2019 for three consecutive years to provide reference and reference for colleagues in the industry According to the work arrangement of SFDA, CFDI is responsible for the inspection and follow-up of overseas enterprises In June 2018, CFDI issued the 2017 annual drug inspection report However, in the whole year of 2019, CFDI did not release any report materials related to the 2018 overseas drug inspection, so this paper is the 2018 and 2019 overseas drug inspection summarized and sorted out according to the information on CFDI official website and nmap official website See Table 1 for details Table 1-summary of overall inspection in 2017-2019 Analysis: 1 - according to the 2017 annual drug inspection report, in 2017, CFDI inspected 51 varieties in total, including 36 chemicals, including injection, solid preparation, powder spray, API, etc., 14 vaccines, blood products, biological products for treatment, and 1 botanical drug Throughout the year, overseas inspection drugs include products declared for production, re registration, supplementary application and normal import and sale Mainly in Europe and North America, the number of inspections in India and other countries is increasing Of the 51 on-site inspection varieties, 9 did not meet the GMP requirements or failed From the above data, it can be seen that for a long time in the past, the products of European and American pharmaceutical companies were mainly imported into the Chinese market, so the foreign inspection objects of Chinese pharmaceutical administration departments were mostly in the European and American regions As a new supply group of drugs in Chinese market, Indian pharmaceutical companies have begun to attract the attention of Chinese drug administration departments and began to increase inspection efforts 2 - since CFDI did not issue the 2018 drug inspection report, this part of the analysis is based on the summary of inspection information on nmpa and CFDI official website Compared with the overseas inspection in 2017, the inspection of overseas enterprises in 2018 was significantly weakened; it may be due to the Jilin Changsheng event that the resources of China's CFDI were mainly used for the inspection of domestic biological products enterprises and vaccine enterprises The scope of examination is still in accordance with the following principles: aseptic and biological products are mainly inspected as high-risk products, and drugs imported to China for the first time are mainly inspected 3 - as it is at the beginning of 2020, CFDI has not released the drug inspection report in 2019 This part of analysis is based on the summary of inspection information on nmpa and CFDI official website If it is said that the sudden and significant decrease in the inspection of overseas enterprises in 2018 may be affected by the Changsheng incident in Jilin Province, the inspection of overseas enterprises in 2019 will not continue to improve, which shows that the institutional reform of the State Administration also has a significant impact on some daily work 2.1-2017 analysis of key issues of overseas inspection According to the 2017 annual drug inspection report, in the 2017 CFDI inspection of overseas enterprises, 665 defects were found, including 27 serious defects and 140 major defects The main problems are quality control and quality assurance, document management, sterile drug management, etc Serious defects mainly include inconsistency of production process, failure to declare major changes to China in time, authenticity problems in registration application materials, failure to effectively reduce the risk of product pollution or confusion in production plant facilities, equipment and production operation behavior, failure to effectively control unqualified products, etc In addition, according to the specific information of some cases that failed to pass the inspection disclosed in the 2017 annual drug inspection report, some foreign enterprises have extremely serious compliance problems Here are three examples to focus on: Case 1 The actual production process, production site, inspection items, etc are inconsistent with the registration declaration, or there are major changes, etc., which have been implemented without declaration to China For example, during the preparation of injection oil phase, the actual filtering method and filtering materials are inconsistent with the registration application data; the products released to China are not inspected and the content uniformity is not measured according to the import registration standard; the process prescription is changed; the actual manufacturer and production address are inconsistent with the manufacturer and production address indicated in the import drug registration certificate Resolution: the violation facts shown above are not only the system operation problems in GMP management, but also the inconsistency between most of the pharmaceutical production process and key parameters of overseas enterprises and the registration data of imported drugs in China, which has serious violation risks, and can not guarantee the quality of drugs, which has a continuous impact on the health of Chinese patients The above case also shows that the problem of inconsistent registration process exists not only in Chinese enterprises, but also in overseas pharmaceutical enterprises, which needs to be considered and valued by Chinese pharmaceutical administration departments Case 2 There are serious data reliability problems For example, multiple batches of release test atlas use the materials copied and forged by pasted information strips as the materials submitted for registration review; the original inspection record cannot be provided for on-site inspection; the trial batch number of prescription screening sample is inconsistent with the batch number of related intermediate and finished product inspection, and the trial production record, particle content determination, release measurement (finished product), content determination of the same batch of sample( The batch number is inconsistent, etc Analysis: the content of this case is shocking! It can be said that this overseas enterprise does not have any compliance awareness and quality culture It is totally fraudulent and willful! For such products and enterprises, if they can't be found and screened through strict examination, they will cause serious injury to Chinese patients Case 3 The risk of product pollution or confusion cannot be effectively reduced by production plant facilities, equipment and production operation behaviors For example, the injection water injection configuration filling production line and the powder injection preparation production line (the production line has hormone products) are located in the same workshop, sharing the air purification system, and the enterprise has neither conducted risk assessment nor taken effective protective measures to avoid the pollution of hormone products to other products; the filling operator needs to manually press the rubber plug into the aluminum cover, Then place it in the corresponding cavity of the filled three chamber bag; there are many sewage and garbage in the plant area; the anti mosquito measures in the general production area are not effective, the production plant area is always high temperature (up to 45 ℃), there is no cooling measures, the doors and windows cannot be closed; there are many damaged screen windows, many mosquitoes are found in the production site; there are many open feeding or transfer operations, no local protection, etc Analysis: the GMP standard, which was born in 1962 in the United States, aims to control pollution, cross pollution and minimize human error From the above case, the inspected overseas enterprise has no GMP basic awareness and quality awareness in site management, and there is a serious pollution risk, so it should be killed naturally 2.2-2018 analysis of key issues of overseas inspection According to the information on nmpa and CFDI official website, the author summarizes the defects of overseas drug inspection released in 2018 as follows: Resolution: from the above inspection defects, there are also serious problems of inconsistency between the registration process and the actual process in overseas enterprises; if the inspection frequency is relaxed, similar risks will be difficult to find, or it will take a long time to find, which will bring risks to Chinese patients In addition, the more strict inspection of sterile drugs is the consistent style of drug administration agencies around the world, which is also based on the reason that the products are in the high-risk category 2.3-2019 analysis of key issues of overseas inspection According to the information on nmpa and CFDI official website, the author summarizes the defects of overseas drug inspection released in 2019 as follows: Analysis: in the case of 2019, there is also a general inconsistency between the registration process and the actual process in overseas enterprises This really needs the reflection of Chinese pharmaceutical administration First, the compliance awareness of foreign enterprises is indifferent; due to the obvious decrease in the frequency of overseas inspection by Chinese drug administration agencies, overseas enterprises do not attach great importance to the quality of drugs exported to China In addition, China's cumbersome change management regulations are also one of the reasons for the difficulty of process change 3.1 summary of inspection on overseas enterprises in 2018 As the National Bureau did not issue the 2018 annual drug inspection report, the author makes statistics according to the information on CFDI official website as follows: Note: the statistical information date of the above table is from January 1, 2018 to December 31, 2018 Analysis: according to the above statistics, 24 enterprises and 24 products were involved in the overseas inspection in 2018 Compared with the overseas inspection in 2017, the inspection of overseas enterprises in 2018 was significantly weakened; it may be due to the Jilin Changsheng event that the resources of China's CFDI were mainly used for the inspection of domestic biological products enterprises and vaccine enterprises From the perspective of inspection content, the following principles should be followed: sterile products, biological products and other high-risk products should be focused on inspection, and enterprises registered in China for the first time should be focused on inspection It is worth noting that rituximab injection (stock solution) from Roche, Switzerland, has been inspected, which shows that the policy of China's pharmaceutical administration has been loosened on whether the stock solution and preparation of biological products can be separated At present, the author understands that there are still many provincial bureaus that are conservative about whether the original solution and preparation of biological products are allowed to be set up separately, which indicates that Chinese laws and regulations need to be further clarified and unified to promote the rapid development of enterprises in China 3.2-2019 inspection summary of overseas enterprises At the beginning of 2020, the inspection report of CFDI on overseas pharmaceutical enterprises in 2019 has not been released According to the information statistics of CFDI official website, the author is as follows: Note: the statistical information date of the above table starts from January 1, 2019 and ends on January 11, 2020 Analysis: from the above data statistics of inspection in 2019, CFDI conducted 15 overseas drug inspections in 2019 There are 20 specific products involved Among the 20 drugs examined, there are two low-risk products, difamin tablets and chlorphenamine maleate It is estimated that difamin tablets are the first to be imported into the Chinese market, while chlorphenamine maleate APIs are in short supply in China The former synthesis of this API will use the intermediates strictly controlled by the United Nations (which can be used to make weapons) The remaining 18 products inspected in 2019 are all high-risk products, such as injection, inhalation solution, biological products, blood products, etc.; these situations also indicate that CFDI adheres to the basic principles and work direction of controlling high-risk products under the current limited technical force Part IV: Forecast of overseas inspection trend in 2020 It is predicted that 1-cfdi will strengthen the inspection of overseas innovative drugs According to the above information and data, combined with the development trend of the industry, CFDI of the State Food and drug administration is facing more inspection tasks as more global innovative drugs are registered in the Chinese market Many foreign innovative products approved in 2019 have not been implemented
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.