On November 29, the State Food and Drug Administration publicly solicited opinions on the "Regulations on the Supervision and Management of Drug Quality by Drug Marketing Authorization Holders". The "Regulations" have a total of 35 articles.
The "Regulations" define the person in charge of the enterprise: The person in charge of the enterprise in these regulations includes the legal representative and the main person in charge of the enterprise.
Chinese herbal medicine slices and formula granules enterprises: Chinese herbal medicine slices production enterprises and Chinese herbal formula granules production enterprises shall refer to these regulations for implementation.
Requirements for special categories of drugs: narcotic drugs, psychotropic drugs, toxic drugs for medical use, pharmaceutical precursor chemicals, radioactive drugs, vaccines and other biological products, etc., if there are special regulations, follow their regulations.
In order to urge drug marketing authorization holders to fulfill their main responsibility for drug quality and further strengthen the quality supervision and management of drugs throughout their life cycle, the National Medical Products Administration has drafted the "Regulations on the Supervision and Management of Drug Quality by Drug Marketing Authorization Holders (Draft for Comments)", and now solicits public opinions. Please send your comments to the email yaopinjianguan-2 nmpa.gov.cn before December 9, 2022. Please indicate "Feedback on the Implementation of the Regulations on the Management of the Main Responsibility of the Holder" in the email title.
Attachment: Regulations on the Supervision and Management of Drug Quality by Drug Marketing Authorization Holders (Draft for Comments)
General Department of the National Medical Products Administration
November 29, 2022
400-900-1882 
info@hillgene.com 
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