Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
Monthly Recap: China Pharmaceutical Regulatory Updates | December 2022 Check out China's pharmaceutical regulatory updates in December 2022: 1. China NMPA Adds OTC Status to a Former Prescription Drug; 2. China NMPA Releases the 62nd List of RLDs; 3. China NMPA Issues Regulation on Supervising MAH as the Main Responsible Entity for Drug Safety; 4. China NMPA Requires Licenses for Importing and Exporting Anesthetics and Psychoactive Drugs; 5. China CDE Specifies Requirements for Electronic Submission of Drug Applications...
Jan 09, 2023
[Updated] China Conditionally Approves MSD's Molnupiravir for COVID-19 Treatment On Dec. 29, 2022, China NMPA conditionally approved Merck Sharp & Dohme (MSD)’s Molnupiravir Capsules (brand name: Lagevrio) for COVID-19 treatment.
Jan 05, 2023
China Levies Zero Tariff on Active Pharmaceutical Ingredients of COVID-19, Cancer, and Rare Disease Drugs According to China's 2023 Tariff Adjustment Plan, tariffs are provisionally lowered to zero for 22 categories of active pharmaceutical ingredients of medicines for treating COVID-19, cancer, and rare diseases.
Jan 05, 2023
China Requires Electronic Submission of All Drug Registration Application Documents from Jan. 1, 2023 China NMPA requires that all documents for drug registration applications, as well as supplemental documents sent during the review, shall be submitted electronically in compact disks with no paper required, from Jan. 1, 2023.
Jan 01, 2023
Change Control for Transport of Medicinal Products 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.
Dec 20, 2022
China Issues Draft Regulation on MAH as Main Responsibility Entity for Drug Quality Drug marketing authorization holders (MAH) in China are required to establish drug quality management system and be responsible for the safety, effectiveness, and quality controllability during drug development, manufacture, supply, and use according to the Drug Administration Law, Good Manufacturing Practices (GMP), Good Supply Practices (GSP), Good Pharmacovigilance Practices (GVP), and relevant regulations.
Dec 16, 2022
China Requires Online Drug Sellers and E-commerce Platforms to File Necessary Information On Nov. 31, 2022, China National Medical Products Administration specified the requirements for online drug sellers and online drug transaction platforms to file necessary information to local regulators.
Dec 14, 2022
- [Updated] China Adds 111 Drugs to 2022 National Reimbursement Drug List
- [Updated] Drug Application Fees for FY 2023 in China and the U.S.
- Monthly Report: New Drug Approvals in China | January 2023
- Monthly Recap: China Pharmaceutical Regulatory Updates | January 2023
- [New Resource] China Marketing Authorization Holder (MAH)'s Responsibilities for Drug Quality