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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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Monthly Recap: China Pharmaceutical Regulatory Updates | November 2022
Check out China's Pharma Regulatory Updates for November 2022: 1. China NMPA Renews Classifications of Sodium Hyaluronate Products;
2. China NMPA Requires All Drug Registration Application Documents to Be Submitted in Compact Disks; 3. China NMPA Consults on Chemical API Registration Renewal Regulation, and more.
Dec 09, 2022
REGULATION
Law & Regulation
Guideline
Pharmacopoeia
Reference Listed Drug (RLD)
GMP
Clinical Trial
NRDL
Health Insurance
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OTC Drug
Cancer
Monthly Recap: China Pharmaceutical Regulatory Updates | September 2022
Find out the latest pharmaceutical regulatory updates in China: 1. China SAMR to Permit Online Sales of Prescription Drugs Nationwide; 2. China NMPA Grants One Rx-to-OTC Switch; 3. China NMPA Releases 183 RLDs; 4. China CFDI Consults on Inspection Guidance for Blood Products; 5. China NHSA Announces 343 Drugs Passing the Format Review for NRDL; 6. China CDE Releases Pharmaceutical Guidelines; 7. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards and Guideline
Oct 03, 2022
REGULATION
Law & Regulation
Guideline
Pharmacopoeia
Reference Listed Drug (RLD)
Clinical Trial
Bioequivalence (BE)
Generic Drug
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COVID-19
Monthly Recap: China Pharmaceutical Regulatory Updates | August 2022
Check out China's pharmaceutical regulatory updates in August: NMPA granted OTC status to Omeprazole Enteric-coated Tablets; NMPA released the 57th List of Reference Listed Drugs (RLDs); NHC Adds Azvudine to COVID-19 Diagnosis and Treatment Protocol; NMPA to Adopt ICH E8 (R1) and E14 Guidelines...
Sep 09, 2022
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | July 2022
Check out the pharma regulatory updates in China: The 7th National Volume-based Procurement (VBP) Includes 327 Drug Products; China CDE Consults on Procedures for Starting For-cause Inspections; China CDE Releases Q&A on Immediate Report of Adverse Drug Reactions in Clinical Trials...
Aug 05, 2022
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | June 2022
Check out the pharmaceutical regulatory updates in China: 1.CDE Issues the 2021 China Drug Evaluation Report; 2. CDE Publishes the 2021 Clinical Trial Report; 3. CDE Consults on Communication Procedures for Pediatric Drug Applicants...
Jul 06, 2022
REGULATION
Law & Regulation
Guideline
Pharmacopoeia
Reference Listed Drug (RLD)
MAH
Marketing Approval
CMC
Clinical Trial
Generic Drug
Cell Therapy
Gene Therapy
Drug Registration
Monthly Recap: China Pharmaceutical Regulatory Updates | May 2022
Check out the May updates on pharma regulations in China: NMPA publishes MedDRA Coding Guidance for ADR Reports...
Jun 08, 2022
REGULATION
Law & Regulation
Guideline
Reference Listed Drug (RLD)
MAH
Pharmacovigilance
Marketing Approval
CMC
Bioequivalence (BE)
Post-market
Generic Drug
Biosimilar
Cancer
New Drug
Monthly Recap: China Pharmaceutical Regulatory Updates | April 2022
Check out China's pharmaceutical regulation updates April 2022: China NMPA releases Pharmacovigilance Inspection Guidelines...
May 05, 2022
REGULATION
Law & Regulation
Guideline
Reference Listed Drug (RLD)
MAH
GMP
Marketing Approval
Post-market
Generic Drug
Vaccine
GCP
COVID-19
Monthly Recap: China Pharmaceutical Regulatory Updates | March 2022
Check out the pharmaceutical regulatory updates in China: NMPA releases the 52th list of reference listed drugs; China NMPA consults on drug MAH's inspection regulation...
Apr 08, 2022
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | February 2022
1. CDE Releases its Work Procedures for Expediting the Review of Marketing Applications of Innovative Drugs (Trial);
2. CDE Consults on the Guidance for Acceptance Review of Active Pharmaceutical Ingredients (API) of Chemical Drugs;
3. CDE Releases the Consultation Draft of Guidance for Acceptance Review of Registration Applications of Traditional Chinese Medicines, Chemical Drugs, and Biological Products (Trial);
4. NMPA Releases the 51st List of Reference Listed Drugs;
5. NMPA Publishes the 2022 Plan for Random Inspection of Medical Devices;
6. NMPA Reveals the List of 208 Medical Devices Approved in January 2022;
7. Guidelines for Pharmaceutical Industry.
Mar 10, 2022
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