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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 | 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
POLICY
China's 9th Volume-based Procurement (VBP) of Drugs to Impact Market Valued Over USD 2.32 Billion
Out of the 42 drugs to be enrolled in China’s 9th VBP, the top 10 best-selling drugs accounted for approximately USD 2.32 billion in sales in 2022. Two drugs—the immediate-release dosage forms of rabeprazole and propofol injections—each exceeded 3.5 USD billion in last year’s sales.
Oct 20, 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
China to Dismiss Overdue Equivalence Evaluation Applications for Generics
On Sept. 25, 2023, China CDE released the draft of the Guidance for the Acceptance Review of Quality and Therapeutic Equivalence Evaluation Applications for Generic Drugs, stating that the CDE will no longer accept equivalence evaluation applications for generic drugs of the same type if they are submitted three years or more after the first generic drug passes the equivalence evaluation.
Sep 28, 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)
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
REGULATION
Law & Regulation
Guideline
Reference Listed Drug (RLD)
Marketing Approval
CMC
Clinical Trial
Bioequivalence (BE)
Generic Drug
Drug Registration
China May Disallow Applications of Generic Drugs with No RLDs and Low Clinical Value
On May 24, China CDE released the draft Notice of Generic Drug Study Without Reference Listed Drugs (RLDs). The draft states the precondition for developing copycats of drugs which are not listed in China’s RLD Catalog—the drugs have to be widely used, with no alternatives, and with benefits trumping risks.
Jun 05, 2023
REGULATION
China May Delist Ineligible Reference Listed Drugs (RLDs) of Chemical Generic Drugs
On Mar. 24, 2023, China NMPA released the Procedures for Adjusting Reference Listed Drugs (RLDs) of Chemical Generic Drugs (Trial) with immediate effect. RLDs are reference drugs to which generic drugs should be equivalent in safety and efficacy. NMPA finds that some listed RLDs no longer meet the Chinese Pharmacopoeia standards or the current technological requirements. That’s why NMPA formulates and implements the RLD Adjustment Procedures.
Mar 28, 2023
REGULATION
Pharmacopoeia
MAH
Marketing Approval
CMC
Clinical Trial
Bioequivalence (BE)
NRDL
Drug Registration
New Drug
Real World Data
Packaging
Monthly Recap: China Pharmaceutical Regulatory Updates | February 2023
China's regulatory updates in Feb. 2023: 1. China NMPA Issues TCM Registration Rules; 2. China CDE Rolls Out Pharmaceutical Guidelines; 3. Chinese Pharmacopoeia Commission Issues Draft Standards
Mar 07, 2023
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