BaiPharm Pharmaceutical Regulatory News – Dec 27, 2022
Ruiou BaiPharm Service Co.,Ltd ’s second LinkedIn newsletter, where you'll find the latest pharmaceutical regulatory updates and industry activities in China in the past two weeks.
China Issues Draft Regulation on MAH as Main Responsibility Entity for Drug Quality?
16 December, 2022
On Nov. 29, 2022, China National Medical Products Administration (#NMPA) released the draft of?Administrative Rules on Supervising Marketing Authorization Holder (#MAH) as the Main Entity to Fulfill Responsibilities for Drug Quality.
China’s drug MAH system has been implemented nationwide since the revised?Drug Administration Law?came into force in 2019. The obligations for MAHs are mentioned in?Drug Administration Law, and is now detailed in the?Administrative Rules.
Some highlights of the?Administrative Rules:
Management of #APIs, Excipients and Packaging Materials
China Requires Online Drug Sellers and E-commerce Platforms to File Necessary Information
14 December 2022
On Nov. 31, 2022, China National Medical Products Administration (NMPA) specified the requirements for online drug sellers and online drug transaction platforms to file necessary information to local regulators.
领英推荐
The information filing is required in the?Administrative Measures for Supervising Online Sales of Drugs?(hereafter referred to as the Measures), which took effect on Dec. 1, 2022. The?Measures?permits prescription drugs to be sold online in addition to #OTC drugs.
China's GSP Permits Drug Retailers to Entrust Delivery to Third Party
14 December 2022
On Nov. 30, 2022, China National Medical Products Administration (NMPA) released the?Sixth Appendix to Good Supply Practices (GSP) for Pharmaceuticals: Quality Management of Drug Retail Delivery, which will take effect on Jan. 1, 2023.?
The?Appendix?applies to the delivery after drug retail transactions, including online transactions.
The quality management requirements in the?Appendix?cover personnel, internal review system, delivery entrustment, delivery methods, packaging, return of goods, etc.
Change Control for Transport of Medicinal Products
20 December, 2022
Any change from design or predefined processes requires risk assessment and potential impact evaluation for both the transport process and, consequently, the product. This article discusses the importance of having a structured, compliant Change Control (CC) process in place for medicinal product manufacturers as well as for their qualified logistics vendors.