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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 | April 2024
Check out the latest pharma regulatory updates in China: 1. China NMPA Adopts Electronic Documentation for Administrative Licensing in Drug Registration, 2. China NMPA Rolls out the 79th RLD List, 3. China Enhances Supervision and Management of Drug Operations, 4. China Expedites Process for Transferring Overseas Drug Manufacturing Sites to China...
May 13, 2024
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | March 2024
Check out the latest pharma regulatory updates in China: 1. NMPA Rolls Out the 78th RLD List; 2. NMPA Grants Six Rx-to-OTC Switches; 3. NMPA Implements Electronic Submission for Import and Export License Applications of Anesthetics and Psychotropics; 4. NMPA Issues Regulation on Exploratory Research on Drug Sampling and Testing...
Apr 12, 2024
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | December 2023
Check out the pharma regulatory updates in Dec 2023: 1. China Encourages the Development of 39 Generic Drugs; China CDE Updates eCTD Structure for Drug Registration Applications; 3. China Releases the 74th List of Reference Drugs...
Jan 04, 2024
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
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
REGULATION
Law & Regulation
Guideline
Pharmacopoeia
Reference Listed Drug (RLD)
GMP
Clinical Trial
NRDL
Health Insurance
Generic Drug
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
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
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