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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
China to Streamline Process for Transferring Overseas Drug Manufacturing Sites to China
The draft brings encouraging news as it suggests that China may accept the original registration application dossier of overseas drugs, including documents related to chemistry, manufacturing, and controls, non-clinical and clinical studies, if they remain applicable.
Jan 25, 2024
REGULATION
Law & Regulation
Guideline
Reference Listed Drug (RLD)
Marketing Approval
CMC
Clinical Trial
Bioequivalence (BE)
Generic Drug
Drug Registration
China May Disallow Applications of Generic Drugs with No RLDs and Low Clinical Value
On May 24, China CDE released the draft Notice of Generic Drug Study Without Reference Listed Drugs (RLDs). The draft states the precondition for developing copycats of drugs which are not listed in China’s RLD Catalog—the drugs have to be widely used, with no alternatives, and with benefits trumping risks.
Jun 05, 2023
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | March 2023
China regulatory updates in Mar. 2023: 1. China NMPA Grants OTC Status to Two Former Prescription Drugs; 2. China NMPA Releases Two RLD Lists; 3. China NMPA Releases RLD Adjustment Procedures; 4. China CDE Trials Work Procedures for Expediting the Review of Innovative Drug’s Marketing Authorization Application; 5. China CDE Consults on Dossier Requirements for Moving the Manufacturing Site to China...
Apr 13, 2023
REGULATION
Law & Regulation
Guideline
Marketing Approval
Priority Review
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
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
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