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REGULATION
BaiPharm Regulatory Database Is Online: A Useful Tool to Search for China’s Pharma Guidelines, Regulations, and Standards
ChemLinked BaiPharm Regulatory Database is a useful tool for ChemLinked users, especially overseas pharmaceutical companies that aim for China market, to search for China’s official guidelines, regulations, and Chinese Pharmacopoeia standards.
Feb 16, 2023
REGULATION
Law & Regulation
Guideline
Pharmacopoeia
Reference Listed Drug (RLD)
Marketing Approval
NRDL
Drug Registration
COVID-19
GLP
Monthly Recap: China Pharmaceutical Regulatory Updates | January 2023
Check out the regulatory updates in Jan. 2023: 1. China Issues the 2022 National Reimbursement Drug List; 2. China Approves Two Homegrown Drugs for COVID-19; 3. China Releases Two Lists of RLDs; 4. China Issues GLP Certification Regulation; 5. China Rolls Out Pharmaceutical Guidelines; 6. Chinese Pharmacopoeia Commission Issues Drafts of Standards
Feb 06, 2023
REGULATION
Law & Regulation
Pharmacovigilance
Marketing Approval
Volume-based Procurement
Generic Drug
Drug Registration
E-commerce
2022 Recap: Top 10 BaiPharm Stories on China Pharmaceutical Regulations
ChemLinked BaiPharm Portal has been tracking and interpreting China’s pharmaceutical regulations during the year of 2022. Here are the top 10 stories we selected for you to grasp China’s regulatory dynamics.
Jan 13, 2023
REGULATION
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
REGULATION
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
REGULATION
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
REGULATION
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
REGULATION
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
REGULATION
Law & Regulation
Guideline
Pharmacopoeia
MAH
CMC
Clinical Trial
Bioequivalence (BE)
Innovative Drug
API
Drug Registration
E-commerce
Packaging
Excipient
Monthly Recap: China Pharmaceutical Regulatory Updates | November 2022
Check out China's Pharma Regulatory Updates for November 2022: 1. China NMPA Renews Classifications of Sodium Hyaluronate Products;
2. China NMPA Requires All Drug Registration Application Documents to Be Submitted in Compact Disks; 3. China NMPA Consults on Chemical API Registration Renewal Regulation, and more.
Dec 09, 2022
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