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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 | January 2024
A recap of China's pharma regulatory updates in Jan 2024: CDE Conditionally Waives Registration Documents for Overseas Manufactured Drugs, NMPA Outlines Key Considerations for Inspecting Third-party Platforms for Online Drug Sales...
Feb 06, 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
China Requires ANDAs Without Reference Drugs to Demonstrate Clinical Value
For generic candidates without reference listed drugs, China's NMPA requires the applicant to conducting CM) studies to prove the proposed generic drug’s equivalence to the marketed drug with the same API, assesses and demonstrates the proposed drug’s clinical value, and submits a communication application for having a type-III meeting with CDE.
Oct 17, 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
China Clarifies Human Genetic Resources (HGRs) and Foreign Stakeholders in International Clinical Researches
China’s Implementation Rules for the Administrative Regulations of Human Genetic Resources, declared by the Ministry of Science and Technology (MOST), took effect on July 1, 2023.
Jul 21, 2023