An overview of the drug administration policies in the first quarter, these changes are closely related to you!

At present, the task of preventing and controlling the new crown pneumonia epidemic in China is still arduous, and the matching of drug supervision capabilities with the needs of supervision tasks has been further improved.

01

Publishing the Cosmetics Production Quality Management Specification

On January 6, the State Food and Drug Administration issued the "Announcement on Issuing the "Good Manufacturing Practice for Cosmetics" (No.

02

Carry out special rectification of drug safety 

On January 24, the State Food and Drug Administration deployed in-depth special rectification actions for drug safety at the 2022 National Drug Supervision and Administration and Party Style and Clean Government Work Conference, requiring drug regulatory authorities at all levels to adhere to both the symptoms and root causes, and highlight the problem orientation.

03

The "two highs" released the "Interpretation on Several Issues Concerning the Application of Law in Handling Criminal Cases of Endangering Drug Safety" 

On March 3, the Supreme People's Court and the Supreme People's Procuratorate issued the "Interpretation on Several Issues Concerning the Application of Law in Handling Criminal Cases Endangering Drug Safety", which will come into force on March 6, 2022

04

Guiding Opinions on Benchmarks for Administrative Punishment of Traditional Chinese Medicine Decoction Pieces

On February 21, the General Department of the State Food and Drug Administration issued the "Guiding Opinions on the Principles for the Application of Paragraph 2 of Article 117 of the Drug Administration Law of the People's Republic of China"

05

New Measures for Medical Device Supervision Announced

On March 22, the State Administration for Market Regulation announced the "Measures for the Supervision and Administration of Medical Device Production" (Order No.

On June 1, 2021, the newly revised "Regulations on the Supervision and Administration of Medical Devices" came into effect, and the original supporting regulations of the medical device supervision department are facing "establishment, abolition and reform"
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The two measures announced this time are two new measures in the production and operation of medical devices following the "Administrative Measures for Registration and Filing of Medical Devices" and "Administrative Measures for Registration and Filing of In Vitro Diagnostic Reagents" issued on August 26, 2021.
regulations
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The "Measures for the Supervision and Administration of Medical Device Production" consists of 6 chapters and 81 articles.
One of the highlights is to clarify the power of supervision and management of the production of Class I medical devices
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This move will fully mobilize the enthusiasm of the city and county market supervision departments, further improve the quality of filing, enhance the efficiency of supervision, expand the coverage of supervision and increase the frequency of supervision, and help to solve the practical problem of separation of filing and supervision of first-class medical devices
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The "Measures for the Supervision and Administration of the Operation of Medical Devices" has 6 chapters and 73 articles, of which there are two obvious changes
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First, the definition of "wholesale of medical devices" is re-clarified, and the business behavior of medical devices that sell medical devices to other units with reasonable use needs is added
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Since the outbreak of the new crown pneumonia epidemic, it has become the norm for ordinary enterprises, institutions or social organizations to purchase large quantities of medical equipment such as medical masks and medical protective clothing.
This definition will facilitate the purchase and sale of such medical equipment
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The second is to increase the penalties for relevant business violations, raising the maximum fine from 30,000 yuan in the old method to 200,000 yuan in the current new method
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