China to Issue Electronic Drug Registration Certificates from November 2022

From Nov. 1, 2022, China National Medical Products Administration (NMPA) will issue drug registration certificates in electronic version, which is as …

Pharma
Oct. 31st, 2022

How to Sell OTC Drugs to China via Cross-Border E-Commerce (CBEC)

To market over-the-counter (OTC) drugs in China, stakeholders used to obey the same documentation requirements and marketing authorization application…

Pharma
Oct. 14th, 2022

Sept 2022: New Drug Approvals in China

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

Pharma
Oct. 12th, 2022

Sept 2022 | China Pharmaceutical Regulatory Updates

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

Pharma
Oct. 11th, 2022

China ANDA NDA: How to Get China’s Marketing Authorization for OTC Drugs

In China, the marketed drugs have been divided into prescription drugs (Rx drugs) and non-prescription drugs since 2000. Non-prescription drugs, also …

Pharma
Sep. 22nd, 2022

China Pharmaceutical Regulatory Updates | August 2022

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

Pharma
Sep. 14th, 2022

FAQs on BE Study, Reference Listed Drug, and Quality & Therapeutic Equivalence Evaluation | China CDE

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

Pharma
Sep. 09th, 2022

Chinese Pharmacopoeia: Understanding 42 Guidelines [English Version Available]

Chinese Pharmacopoeia is an official collection of drug standards, covering drug development, production, sale, utilization, supervision, and control …

Pharma
Sep. 05th, 2022

How to Get Drug Marketing Authorization Holder (MAH) Agency Services in China

In China, pharmaceutical companies or research institutes with drug registration certificates are drug marketing authorization holders (MAHs). Accordi…

Pharma
Aug. 29th, 2022

China Suspends UCB’s Antiepileptic Drug “Keppra” from Import, Sale, and Use

On Aug. 24, China National Medical Products Administration (NMPA) suspended the import, sale, and use of UCB Pharma S.A.’s Levetiracetam Concent…

Pharma
Aug. 29th, 2022
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