Baipharm
ChemLinkedMarketChemicalFoodCosmeticBaiPharm Agrochemical Japan
News
Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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
Law & Regulation Reference Listed Drug (RLD) MAH Marketing Approval Volume-Based Procurement
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
Law & Regulation Reference Listed Drug (RLD)
Monthly Recap: China Pharmaceutical Regulatory Updates | August 2021 1. NMPA Releases the 44th Batch of Reference Listed Drugs; 2. SAMR to Enforce New Rules for Medical Device and IVD Reagent Registration/Filing; 3. NMPA Announces Four Rx-to-OTC Switches...
Sep 30, 2021
12 Next
Most Popular