News
Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
Hot topic

REGULATION
Law & Regulation
MAH
Pharmacovigilance
Marketing Approval
Priority Review and Approval
Medical Insurance
Innovative Drug
Generic Drug
Rare Disease
Drug Registration
New Drug
China Encourages Innovative Drug R&D in Revised Draft of Regulations for Implementing the Drug Administration Law
Find out the highlights in revised draft of the Regulations for Implementation of the Drug Administration Law: pharmaceutical innovation, acceptance of foreign clinical data, support the development of pediatric and rare disease drugs...
May 13, 2022

INDUSTRY
MAH
Marketing Approval
Priority Review and Approval
Innovative Drug
Generic Drug
Biological Product
Cancer
Drug Registration
New Drug
Monthly Report: New Drug Approvals in China | April 2022
In April 2022, China NMPA approved 23 new drugs, including 20 chemical drugs and 3 biological products.
May 12, 2022

INDUSTRY
Marketing Approval
Priority Review and Approval
Innovative Drug
Generic Drug
Biological Product
Cancer
Cardiovascular Disease
Rare Disease
Drug Registration
New Drug
Monthly Report: New Drug Approvals in China | March 2022
In March 2022, China NMPA approved 23 new drugs, including 15 chemical drugs and 8 biological products.
Apr 07, 2022

INDUSTRY
Marketing Approval
Priority Review and Approval
Innovative Drug
Generic Drug
Biological Product
Cancer
Drug Registration
New Drug
COVID-19
Monthly Report: New Drug Approvals in China | February 2022
In February 2022, China NMPA approved 16 new drugs, including 12 chemical drugs and 4 biological products. Among the newly approved drugs, Pfizer’s Paxlovid is the first foreign drug against COVID-19 to receive marketing authorization in China.
Mar 11, 2022

REGULATION
Law & Regulation
Marketing Approval
Clinical Trial
Priority Review and Approval
NRDL
Volume-Based Procurement
Medical Insurance
Innovative Drug
API
Rare Disease
New Drug
The 15th Rare Disease Day: China's Policy & Market Overview
China tries to make rare disease drugs available to more patients via measures like expediting the marketing approval of the drugs and reimbursing part of the medical expenses. Meanwhile, the rare disease treatment market is expanding rapidly.
Mar 04, 2022

REGULATION
Law & Regulation
Marketing Approval
Priority Review and Approval
Innovative Drug
Drug Registration
New Drug
China to Expedite Marketing Approval of Innovative Drugs
China CDE plans to expedite the marketing approval of inovative drugs with Breakthrough Therapy Designation (BTD). Technical review will be completed within 130 workdays for the innovative BTD drugs' marketing applications.
Mar 03, 2022

INDUSTRY
Biogen's Drug for Rare Disease SMA Gets Access to More Patients in China Due to NRDL
In December 2021, Biogen cut the price of Spinraza (Nusinersen Sodium Injection) from 700,000 yuan per dose to 33,000 yuan per dose to get a place in China’s National Reimbursement Drug List (NRDL). The move makes Spinraza gain access to more spinal muscular atrophy (SMA) patients in China.
Feb 14, 2022

REGULATION
Law & Regulation
Reference Listed Drug (RLD)
Marketing Approval
Priority Review and Approval
Innovative Drug
Generic Drug
Drug Registration
New Drug
How Will China Regulate and Boost Pharmaceutical Industry by 2025
At the end of 2021, China announced its National Plan for Promoting Drug Safety and the High-quality Development of the Pharmaceutical Industry during the 14th Five-Year Plan (2021-2025). To realize the 2035 vision which includes an internationally-advanced drug regulatory system, China sets tasks to be completed by 2025.
Jan 14, 2022

REGULATION
Law & Regulation
Pharmacopoeia
MAH
Pharmacovigilance
Marketing Approval
Priority Review and Approval
Volume-Based Procurement
Top 10 BaiPharm Stories of China's Pharmaceutical Regulations | 2021 Recep
ChemLinked BaiPharm Portal has been delivering and decoding China's pharmaceutical regulations to help international drug makers access the Chinese market. Here are the 10 regulatory topics that our readers are most concerned about in 2021.
Jan 07, 2022

INDUSTRY
Marketing Approval
Priority Review and Approval
Innovative Drug
Generic Drug
Biological Product
Biosimilar
Drug Registration
New Drug
Monthly Report: New Drug Approvals in China | Oct. 2021
In Oct. 2021, China's NMPA granted marketing authorization approvals to 11 new drugs, including Takeda's VOCINTI and Sanofi's Clopidogrel Bisulfate and Aspirin Tablets.
Nov 08, 2021
Most Popular
- How to Sell OTC Drugs to China Through Cross-Border E-Commerce
- China NMPA Announces Key Points for Pharmacovigilance Inspections
- China Releases MedDRA Coding Guidance for Adverse Drug Reaction (ADR) Reports
- China Implements New Rules on Drug MAH's Annual Reports
- Beijing IP Court Rules on China's First Drug Patent Linkage Litigation Case

