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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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INDUSTRY
Law & Regulation
Reference Listed Drug (RLD)
Marketing Approval
Bioequivalence (BE)
Drug Registration
CPhI & BaiPharm Event: Generic Drug Application Procedures in China
On June 22, BaiPharm is going to co-organize a webinar with CPhI China on the topic of Generic Drug Application Procedures in China.
Jun 21, 2022

REGULATION
Law & Regulation
CDE Guideline
Pharmacopoeia
Reference Listed Drug (RLD)
MAH
Marketing Approval
CMC
Clinical Trial
Generic Drug
Cell Therapy
Gene Therapy
Drug Registration
Monthly Recap: China Pharmaceutical Regulatory Updates | May 2022
Check out the May updates on pharma regulations in China: NMPA publishes MedDRA Coding Guidance for ADR Reports...
Jun 08, 2022

REGULATION
Law & Regulation
CDE Guideline
Reference Listed Drug (RLD)
MAH
Pharmacovigilance
Marketing Approval
CMC
Bioequivalence (BE)
Post-market
Generic Drug
Biosimilar
Cancer
New Drug
Monthly Recap: China Pharmaceutical Regulatory Updates | April 2022
Check out China's pharmaceutical regulation updates April 2022: China NMPA releases Pharmacovigilance Inspection Guidelines...
May 05, 2022

REGULATION
Law & Regulation
CDE Guideline
Reference Listed Drug (RLD)
MAH
GMP
Marketing Approval
Post-market
Generic Drug
Vaccine
GCP
COVID-19
Monthly Recap: China Pharmaceutical Regulatory Updates | March 2022
Check out the pharmaceutical regulatory updates in China: NMPA releases the 52th list of reference listed drugs; China NMPA consults on drug MAH's inspection regulation...
Apr 08, 2022

REGULATION
Law & Regulation
CDE Guideline
Reference Listed Drug (RLD)
Marketing Approval
DMF
Biological Product
API
Drug Registration
New Drug
Monthly Recap: China Pharmaceutical Regulatory Updates | February 2022
1. CDE Releases its Work Procedures for Expediting the Review of Marketing Applications of Innovative Drugs (Trial);
2. CDE Consults on the Guidance for Acceptance Review of Active Pharmaceutical Ingredients (API) of Chemical Drugs;
3. CDE Releases the Consultation Draft of Guidance for Acceptance Review of Registration Applications of Traditional Chinese Medicines, Chemical Drugs, and Biological Products (Trial);
4. NMPA Releases the 51st List of Reference Listed Drugs;
5. NMPA Publishes the 2022 Plan for Random Inspection of Medical Devices;
6. NMPA Reveals the List of 208 Medical Devices Approved in January 2022;
7. Guidelines for Pharmaceutical Industry.
Mar 10, 2022

REGULATION
Law & Regulation
CDE Guideline
Reference Listed Drug (RLD)
Marketing Approval
Clinical Trial
Volume-Based Procurement
Generic Drug
Biosimilar
New Drug
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 and Approval
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
CDE 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
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
Most Popular
- China Releases MedDRA Coding Guidance for Adverse Drug Reaction (ADR) Reports
- Generic Drug Application (ANDA) in China
- Monthly Report: New Drug Approvals in China | April 2022
- China Encourages Innovative Drug R&D in Revised Draft of Regulations for Implementing the Drug Administration Law
- Monthly Recap: China Pharmaceutical Regulatory Updates | May 2022

