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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | February 2024
Check out the pharma regulatory updates in February 2024: 1. NMPA Issues the 2023 Drug Evaluation Report 2. NMPA Rolls out the 76th and 77th lists of RLDs 3. NMPA Specifies Administrative Penalties for Drug-related Illegalities 4. China Releases Pharmaceutical Guidelines 5. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards
Mar 13, 2024
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | November 2023
Check out the latest pharma regulatory updates in China: 1. China NMPA Applies for PIC/S Membership; 2. China to Adopt System for E2B (R3) Electronic Transmission of ICSRs; 3. China NMPA Grants Three Rx-to-OTC Switches; 4. China Includes 195 Drug Products in Its 9th National VBP; 5. China NMPA Issues Inspection Regulation on Clinical Trial Institutions; 6. China NMPA Consults on Anesthetics and Psychotropics Regulations; 7. China CDE Releases Pharmaceutical Guidelines; 8. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards
Nov 30, 2023
REGULATION
Law & Regulation
Pharmacopoeia
CMC
Clinical Trial
Bioequivalence (BE)
Generic Drug
Biological Product
New Drug
GSP
Monthly Recap: China Pharmaceutical Regulatory Updates | October 2023
China pharma regulatory updates for Oct 2023: 1. NMPA Enforces Regulation on API Registration Renewal; 2. NMPA Tightens Regulation on Outsourced Manufacturing for MAHs; 3. NMPA and NHC Announce Chinese Pharmacopoeia 2020 Edition’s 1st Addendum; 4. NMPA Requires ANDAs Without RLDs to Demonstrate Clinical Value...
Nov 08, 2023
REGULATION
Chinese Pharmacopoeia 2020 Edition's 1st Addendum: 54 Additions and 607 Revisions
On Oct.13, 2023, China’s NMPA and NHC jointly announced the release of the first Addendum to the Chinese Pharmacopoeia 2020 Edition. It was stated that the Addendum has been compiled and is planned to be implemented on March 12, 2024.
Oct 13, 2023
REGULATION
Law & Regulation
Guideline
Pharmacopoeia
Innovative Drug
Generic Drug
Rare Disease
Cell Therapy
Gene Therapy
Monthly Recap: China Pharmaceutical Regulatory Updates | September 2023
China pharma regulatory updates in Sept. 2023: 1. NMPA Publishes the 2022 China Drug Evaluation Report; 2. NHC Releases the 2nd Catalog of Rare Diseases; 3. NMPA Adjusts Anesthetic and Psychotropic Drug Catalogs; 4. CDE Unveils 2022 Report on the Progress of New Drug Clinical Trials in China; 5. NMPA Grants Three Rx-to-OTC Switches; 6. ICH, NMPA, and CDE Release Pharmaceutical Guidelines; 7. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards
Oct 08, 2023
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | August 2023
China pharma regulatory updates in Aug 2023: 1. China Consults on Conditional Approval Process; 2. China Rolls out 71st and 72nd Lists of RLDs; 3. China Grants Two Rx-to-OTC Switches; 4. China Releases Pharmaceutical Guidelines; 5. China Consults on Drafts of Drug Standards
Sep 08, 2023
REGULATION
Law & Regulation
Guideline
Pharmacopoeia
Reference Listed Drug (RLD)
GMP
CMC
Clinical Trial
Bioequivalence (BE)
Cell Therapy
Gene Therapy
Drug Registration
GLP
GSP
Monthly Recap: China Pharmaceutical Regulatory Updates | July 2023
China pharmaceutical regulatory updates in July 2023: 1. China Publishes Administrative Measures for Drug Standards; 2. China Announces Customs Codes of Anesthetics and Psychotropic Drugs; 3. China Rolls out the 70th RLD List; 4. China Grants Four Rx-to-OTC Switches; 5. China Revises Drug Inspection Regulation; 6. China Issues Draft Regulation on Inspection of Clinical Trial Institutions; 7. China Releases Pharmaceutical Guidelines; 8. China Consults on Drafts of Drug Standards
Aug 11, 2023
REGULATION
Law & Regulation
Pharmacopoeia
Reference Listed Drug (RLD)
CMC
Clinical Trial
Generic Drug
OTC Drug
Cell Therapy
New Drug
GLP
Monthly Recap: China Pharmaceutical Regulatory Updates | June 2023
Check out China's pharma regulatory updates in June 2023: 1. NMPA Announces Three Rx-to-OTC Switches; 2. NMPA Releases the 69th RLD List; 3. NMPA Specifies GLP Certification Requirements; 4. NMPA to Make Medication Package Inserts Friendlier to Senior Patients; 5. NMPA Revises Administrative Measures for Drug Inspection; 6. CDE Releases Nine (Three in Effect and Six in Consultation) Pharmaceutical Guidelines; 7. Chinese Pharmacopoeia Commission Consults on One Standard on the Generic Names of Pharmaceutical Packaging Materials
Jul 27, 2023
REGULATION
Law & Regulation
Pharmacopoeia
Reference Listed Drug (RLD)
MAH
Bioequivalence (BE)
Post-market
Generic Drug
OTC Drug
Drug Registration
Monthly Recap: China Pharmaceutical Regulatory Updates | May 2023
China drug regulatory updates in May 2023: 1. China to Tighten Regulation on Drug MAHs That Outsource Manufacture; 2. China May Disallow ANDAs of Generic Drugs with No RLDs and Low Clinical Value; 3. China Outlines Path for Adding Pediatric Medication Information to Authorized Drugs; 4. China Greenlights One Rx-to-OTC Switch; 5. China Releases Two RLD Lists...
Jun 15, 2023
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