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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 | January 2022
1. China Pilots Online Sales of Prescription Drugs in Shenzhen;
2. National Insulin Procurement to Start in May;
3. China NMPA Grants Two Rx-to-OTC Switches;
4. China NMPA Releases the 50th Batch of Reference Listed Drugs;
5. China NMPA Approves 221 Medical Devices;
6. China NMPA Issues Three Industry Standards for Medical Devices;
7. Pharmaceutical Guidelines.
Feb 10, 2022
REGULATION
Law & Regulation
Reference Listed Drug (RLD)
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Drug Registration
New Drug
How Will China Regulate and Boost Pharmaceutical Industry by 2025
At the end of 2021, China announced its National Plan for Promoting Drug Safety and the High-quality Development of the Pharmaceutical Industry during the 14th Five-Year Plan (2021-2025). To realize the 2035 vision which includes an internationally-advanced drug regulatory system, China sets tasks to be completed by 2025.
Jan 14, 2022
REGULATION
Law & Regulation
Guideline
Reference Listed Drug (RLD)
Marketing Approval
Bioequivalence (BE)
OTC Drug
Gene Therapy
Drug Registration
New Drug
Monthly Recap: China Pharmaceutical Regulatory Updates | December 2021
1. China Approves Its First COVID-19 Therapy; 2. China to Decide Whether to Conduct Pre-Approval Inspections Based on Risk Levels; 3. China NMPA Adjusts Over-the-Counter (OTC) Catalog; 4. China NMPA Releases the 49th Batch of Reference Listed Drugs (RLDs); 5. For Medical Devices: Class I Catalog, Emergency Approval Procedures, and Industry Standards; 6. Pharmaceutical Guidelines
Jan 13, 2022
REGULATION
Law & Regulation
Pharmacopoeia
MAH
Pharmacovigilance
Marketing Approval
Priority Review
Volume-based Procurement
Top 10 BaiPharm Stories of China's Pharmaceutical Regulations | 2021 Recep
ChemLinked BaiPharm Portal has been delivering and decoding China's pharmaceutical regulations to help international drug makers access the Chinese market. Here are the 10 regulatory topics that our readers are most concerned about in 2021.
Jan 07, 2022
REGULATION
China to Initiate Pre-Approval Inspections Based on Risk Levels of Drug Registration Applications
China will carry out pre-approval inspections on R&D and manufacturing sites involved in drug registration applications. When necessary, the inspections can extend to relevant API, excipient, packaging material manufacturers, suppliers, and contract organizations.
Dec 24, 2021
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | November 2021
1. China Insulin VBP Tender Result;
2. NMPA Launches Drug Supply Information Submission System;
3. NMPAs Requires Documentation for Import/Export Permit of Analgesics and Antipsychotics;
4. NMPA Announces One Rx-to-OTC Switch;
5. The 48th Batch of Reference Listed Drugs;
6. NMPA Approves 110 Medical Devices;
7. NHC Releases Administrative Measures for National Essential Medicine List (Revised Draft);
8. NMPA Releases Administrative Measures for Quality Supervision in Drug Supply, Distribution and Use (Consultation Draft)...
Dec 16, 2021
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | October 2021
China’s Pharma Regulatory Dynamics in Oct. 2021
1. NMPA Releases IVD Reagent Classification Rules
2. NMPA Greenlights 195 Medical Devices
3. NMPA Publishes Medical Device’s Self-Inspection Rules
4. NMPA Rolls Out the 45th, 46th, and 47th Batches of Reference Listed Drugs
5. NHC Consults on Detailed Rules on the Supervision of Internet-based Diagnosis
6. CDE Releases Pharmaceutical Guidelines
Nov 11, 2021
REGULATION
Law & Regulation
Guideline
Marketing Approval
Clinical Trial
Bioequivalence (BE)
Post-market
Drug Registration
New Drug
Monthly Recap: China Pharmaceutical Regulatory Updates | September 2021
1. China's eCTD Format for Drug Marketing Application Dossiers;
2.1. NMPA Underlines Points for Attention on Implementing Administrative Measures for Medical Device Registration and Filing and Administrative Measures for In Vitro Diagnostic Reagent Registration and Filing.
2.2. NMPA Rolls Out the List of Medical Devices Exempted from Clinical Evaluation3 and the List of In Vitro Diagnostic Reagents Exempted from Clinical Trials;
2.3. NMPA Releases Format Requirements for Medical Devices’ or IVD Reagents’ Registration Application Dossiers and Approval Documents;
2.4. Guidelines on Medical Devices and IVD Reagents;
2.5. NMPA Releases Medical Device Industry Standards;
2.6. NMPA, NHC and NHSA Stipulates Unique Device Identifiers;
3. NMPA granted Aloe Vera Pearl Capsules OTC Status;
4.A Collection of Sept. Guidelines Released by NMPA or CDE
Oct 31, 2021
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