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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 | November 2022
Check out China's Pharma Regulatory Updates for November 2022: 1. China NMPA Renews Classifications of Sodium Hyaluronate Products;
2. China NMPA Requires All Drug Registration Application Documents to Be Submitted in Compact Disks; 3. China NMPA Consults on Chemical API Registration Renewal Regulation, and more.
Dec 09, 2022
REGULATION
Law & Regulation
Guideline
Pharmacopoeia
Reference Listed Drug (RLD)
Clinical Trial
Bioequivalence (BE)
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COVID-19
Monthly Recap: China Pharmaceutical Regulatory Updates | August 2022
Check out China's pharmaceutical regulatory updates in August: NMPA granted OTC status to Omeprazole Enteric-coated Tablets; NMPA released the 57th List of Reference Listed Drugs (RLDs); NHC Adds Azvudine to COVID-19 Diagnosis and Treatment Protocol; NMPA to Adopt ICH E8 (R1) and E14 Guidelines...
Sep 09, 2022
INDUSTRY
Law & Regulation
Reference Listed Drug (RLD)
Marketing Approval
Bioequivalence (BE)
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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
Guideline
Reference Listed Drug (RLD)
MAH
Pharmacovigilance
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CMC
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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
Guideline
Reference Listed Drug (RLD)
Marketing Approval
Bioequivalence (BE)
OTC Drug
Gene Therapy
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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
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