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China Unveils Fifth List of Pediatric Drugs Promoting R&D

On September 9, China’s National Health Commission (NHC), Ministry of Industry and Information Technology (MIIT), National Healthcare Security A…

Pharma

Oct. 31st, 2024

Understanding China’s Medical Device Classifications for Marketing Authorization

To acquire China National Medical Products Administration (NMPA)’s marketing authorization for medical devices, companies need to file or register the…

Pharma

Jun. 29th, 2023

China CDE Q&A: Electronic Drug Application and DMF Filing

On Mar. 3, 2023, China Center for Drug Evaluation (CDE) released six Q&As on drug master file (DMF) filing (Q&A No. 1-2) and drug application’…

Pharma

May. 29th, 2023

China Requires Electronic Submission of Drug Registration Docs from 2023

On Jan. 1, 2023, China National Medical Products Administration (NMPA) started to require that all documents for drug registration applications, as we…

Pharma

May. 29th, 2023

China Marketing Authorization Holder (MAH): Responsibilities for Drug Quality

After consulting on the draft in Nov. 2022, China National Medical Products Administration (NMPA) released the Administrative Rules on Supervising Dru…

Pharma

Feb. 20th, 2023

China’s Good Pharmacovigilance Practices (GVP): Decoding PV Compliance in China

On May 13, 2021, China National Medical Products Administration (NMPA) released the Good Pharmacovigilance Practices (GVP), which has been effective s…

Pharma

Feb. 01st, 2023

China CDE Answers Questions on Drug Application’s Electronic Submission and More

On Jan. 11, 2023, China Center for Drug Evaluation (CDE) released 10 Q&As, including nine questions on the electronic submission of drug applicati…

Pharma

Jan. 18th, 2023

China Clinical Trial Application / Investigational New Drug Application Procedures

In July 2018, China optimized the clinical trial applications (CTA) / investigational new drug (IND) applications’ review and approval procedure…

Pharma

Jan. 13th, 2023

November 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: National…

Pharma

Dec. 14th, 2022

October 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: National…

Pharma

Nov. 09th, 2022

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