China Pharmaceutical Regulatory Updates | July 2022

This is a collection of China’s recent pharmaceutical laws, regulations, policies, and standards, mainly issued by the following authorities: Na…

Pharma
Aug. 10th, 2022

FAQs on Drug Registration Applications & Clinical Trials | China CDE

For frequently asked questions concerning technical issues, China Center for Drug Evaluation (CDE) releases corresponding answers on its website. For …

Pharma
Aug. 09th, 2022

New Drug Approvals in China | July 2022

Editor’s Notes: New drugs in this article refer to Innovative/improved new chemical drugs / biological products that have never been granted mar…

Pharma
Aug. 08th, 2022

Manufacturing Entrustment: Key Points Under China’s Marketing Authorization Holder (MAH) System

From July 22 to 23, the first International MAH Collaboration & Innovation Summit took place in Hangzhou, Zhejiang Province. More than 60 experts,…

Pharma
Jul. 29th, 2022

China Approves First Domestic Oral Drug for COVID-19

On July 25, China National Medical Products Administration (NMPA) granted conditional approval to Chinese domestic company Genuine Biotech’s Azv…

Pharma
Jul. 28th, 2022

China Announces Final Result of the 7th Volume-based Procurement (VBP) for Drugs

On July 18, China National Joint Drug Procure Office announced the official list of 327 products for the 7th volume-based procurement (VBP). The 327 p…

Pharma
Jul. 25th, 2022

Update: China Consults on 46 Pharmaceutical Packaging Material Standards in Pharmacopoeia

Since June 10, 2022, the Chinese Pharmacopoeia Commission has issued the drafts of 46 pharmaceutical packaging standards according to the plan for com…

Pharma
Jul. 21st, 2022

China Seeks Public Advice on Colorant Standards of Drug Excipients [English Form Download for Free]

On July 11, the Chinese Pharmacopoeia (ChP) Commission announced that it would conduct systemic research on the standards of colourants as pharmaceuti…

Pharma
Jul. 21st, 2022

Breaking: Immediate Effect of China’s Vaccine Manufacture & Distribution Rules

On July 8, China National Medical Products Administration (NMPA) released the Administrative Rules on Vaccine Manufacture and Distribution (hereafter …

Pharma
Jul. 18th, 2022

China Consults on 11 Packaging Material Standards in Pharmacopoeia

On July 13, the Chinese Pharmacopoeia (ChP) Commission released the drafts of 3 general chapters and 8 determination methods of rubber closures as pha…

Pharma
Jul. 15th, 2022
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