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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
Law & Regulation
CDE Guideline
Marketing Approval
Priority Review and Approval
NRDL
Health Insurance
Rare Disease
Drug Registration
Real World Data
The 16th Rare Disease Day: China's Efforts to Make Orphan Drugs Available and Affordable
This year’s Feb. 28 marks the 16th International Rare Disease Day. In China, there are around 20 million rare disease patients, with more than 200,000 additional patients each year. China has shown a supportive attitude towards rare disease drug development in a series of official documents. The regulations and policies introduced in this article are significant in terms of the drugs’ marketing authorization review timeline and pricing.
Mar 10, 2023

REGULATION
EDQM: Supplement 11.2 of the European Pharmacopoeia Available
Supplement 11.2 of the European Pharmacopoeia (Ph.Eur.) is now available. This supplemental edition lists several updated monographs that will be implemented on 01 July 2023. All CEP holders (Certificate of Suitability of Monographs of the European Pharmacopoeia holders) are encouraged to align their specifications and thus the respective CEPs to the new monographs.
Mar 09, 2023

REGULATION
Pharmacopoeia
MAH
Marketing Approval
CMC
Clinical Trial
Bioequivalence (BE)
NRDL
Drug Registration
New Drug
Real World Data
Packaging
Monthly Recap: China Pharmaceutical Regulatory Updates | February 2023
China's regulatory updates in Feb. 2023: 1. China NMPA Issues TCM Registration Rules; 2. China CDE Rolls Out Pharmaceutical Guidelines; 3. Chinese Pharmacopoeia Commission Issues Draft Standards
Mar 07, 2023

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
CDE 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
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