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    Home > Active Ingredient News > Drugs Articles > Finally, the gun to cancel the GMP and GSP certification has started!

    Finally, the gun to cancel the GMP and GSP certification has started!

    • Last Update: 2019-10-10
    • Source: Internet
    • Author: User
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    [policies and regulations of pharmaceutical network] on October 8, Zhejiang Provincial Food and Drug Administration issued the announcement on matters related to GMP and GSP certification (hereinafter referred to as the announcement), which made it clear that from December 1, 2019, it will no longer accept matters related to GMP and GSP certification According to the announcement, before December 1, 2019, pharmaceutical manufacturers that have obtained the GMP certificate can apply for the GMP certification six months before the expiry of the corresponding certificate (the validity of the certificate is before June 1, 2020) The enterprise shall be able to accept on-site inspection of certification at any time after application For the pharmaceutical manufacturers that have obtained the GMP certificate, if the validity of the certificate is after June 1, 2020, Zhejiang food and Drug Administration will no longer accept the GMP certification related matters from October 20, 2019 If there is a new or rebuilt workshop or there is a major change, it can apply for certification before December 1 For drug distributors who have obtained the drug GSP certificate, if the certificate is valid after June 1, 2020, they will not accept the relevant matters of drug GSP certification from October 20, 2019 In fact, the news about "GMP / GSP certification will be cancelled" has long been circulating in the industry On October 23, 2017, the amendment to the drug administration law (Draft for comments) mentioned that the certification system of drug production quality management standard and drug trade quality management standard (Articles 10 and 16) would be cancelled In September 2018, Shanghai food and Drug Administration issued the notice of implementation opinions on deepening the reform and optimization of administrative examination and approval of "releasing management service" and proposed "merging GMP certification and GSP certification with drug production license and drug marketing license respectively", which also means that Shanghai has become the real leader in canceling GMP and GSP certification On October 22, 2018, the draft amendment to the drug administration law was submitted for deliberation for the first time, proposing the implementation of the drug listing license holder system, adding a number of relevant provisions, deleting the GMP certification and GSP certification of pharmaceutical enterprises, and changing the drug clinical trial institutions from license management to record management On August 26 this year, the amendment to the drug administration law was formally adopted by a vote The revised Drug Administration Law has 12 chapters and 155 articles This "Drug Administration Law" is the second systematic and structural major revision since it was promulgated in 1984 It will raise the achievements of drug reform and effective practices into laws and provide more powerful legal protection for public health The newly revised Drug Administration Law will come into force on December 1, 2019 Now, Zhejiang Province has released the red head document that no longer accepts GMP and GSP certification, which means that the gun to cancel GMP and GSP certification has been fired! However, canceling the two certifications does not mean deregulation Industry insiders believe that the cancellation of certification does not mean that there is no need, but instead changes to dynamic supervision, which transmits the deepening of "deregulation services" In fact, this will strengthen the relevant responsibilities of drug marketing license holders, and drug manufacturers will also face more regular and strict inspection In general, domestic pharmaceutical enterprises will face more strict supervision in the future, which will penetrate into all aspects of the life cycle of drug production, and strengthen the supervision in the event and after the event This will not only put pressure on pharmaceutical enterprises, but also promote the development of pharmaceutical enterprises in the direction of high quality, high standard and scientific management, and also encourage pharmaceutical enterprises to carry out more drug R & D and innovation.
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