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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 | 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
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
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
INDUSTRY
Law & Regulation
Pharmacopoeia
MAH
Pharmacovigilance
Marketing Approval
Innovative Drug
Drug Registration
New Drug
CRAC-HCF 2021 | Embracing China's Pharma Market With Regulatory Compliance and Industry Insights
Five experts from drug regulation authorities, pharmaceutical companies, and consulting firms decoded drug regulations and analyzed industry dynamics for international pharma companies to develop businesses in the Chinese market.
Nov 17, 2021
INDUSTRY
Law & Regulation
Pharmacopoeia
MAH
Pharmacovigilance
Marketing Approval
Innovative Drug
Drug Registration
New Drug
Online Conference | China Drug Regulation and Pharmaceutical Market
BaiPharm will hold a virtual conference on Nov. 12, as part of the CRAC-HCF 2021 event. We will have five speeches elaborating on China drug regulations and pharmaceutical market. The specific topics include China market entry strategy, Chinese Pharmacopoeia, GVP, MAH, and innovative drug research.
Oct 21, 2021
REGULATION
China Releases Guidance for Declaration of Chemical Drug Changes
On Feb. 10, 2021, China Center for Drug Evaluation issued and started implementing the Guidance for Acceptance and Review of Chemical Drug Changes (Trial). The document addresses supplemental applications that entail the reviews of state-level drug regulatory authorities, including those submitted during clinical trials.
Mar 19, 2021
REGULATION
China Requires Drug Market Authorization Holders to Submit Annual Report
On Dec. 10, 2020, the National Medical Products Administration (NMPA) published the drafts of Administrative Provisions of Annual Drug Reports and Template for the Annual Drug Report, asking for public consultation before Dec. 22, 2020.
Mar 08, 2021
REGULATION
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