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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
REGULATION
Law & Regulation Vaccine E-commerce
China to Ban a List of Drugs from Online Sales As China will permit online sales of OTC and prescription drugs nationwide from Dec. 1, 2022, the list of banned drugs would help improve the supervision of sales by specifying the forbidden product groups.
Nov 07, 2022
INDUSTRY
Marketing Approval Priority Review and Approval Innovative Drug Cancer Diabetes Drug Registration New Drug
Monthly Report: New Drug Approvals in China | October 2022 In October 2022, China NMPA approved 17 new drugs, including 11 chemical drugs and 6 biological products.
Nov 03, 2022
REGULATION
Law & Regulation CMC Clinical Trial Post-market Drug Registration
Monthly Recap: China Pharmaceutical Regulatory Updates | October 2022 Find out the China's pharmaceutical regulatory updates in October: 1. China NMPA Issues New Administrative Measures for Drug Recall; 2. China NMPA Temporarily Extends Deadlines for Submitting Supplemental Documents; 3. China NMPA Consults on GLP Certification Regulation; 4. China NMPA Releases the 61th List of RLDs; 5. China NMPA to Issue Electronic Certificates and Approval Documents; 6. CDE Issues a Series of Guidelines and Rules; 7. ChP Commission Seeks Public Advice on Drug Standards.
Nov 02, 2022
REGULATION
Law & Regulation MAH Marketing Approval Drug Registration
China Starts to Issue Electronic Drug Registration Certificates From Nov. 1, 2022, China NMPA will issue drug registration certificates in electronic version, which is as legally valid as the paper version.
Nov 01, 2022
REGULATION
Law & Regulation MAH Pharmacovigilance Post-market
Drug Recall in China: MAHs Shall Shoulder the Main Responsibility China NMPA's new Administrative Measures for Drug Recall will take effect on Nov. 1, 2022. Different from the previous 2007 version, the new Measures designates drug marketing authorization holders (MAHs), instead of manufacturers, as the main responsible entity for drug recall.
Oct 31, 2022
REGULATION
Law & Regulation Drug Registration GLP
Understanding China's Good Laboratory Practice (GLP) Certification Regulation Draft On Oct. 21, 2022, China NMPA issued the draft of Administrative Measures for Good Laboratory Practice (GLP) Certification for public comments. GLP certification means NMPA inspects and evaluates if research institutes comply with GLP during non-clinical safety evaluation for pharmaceuticals.
Oct 25, 2022
REGULATION
Law & Regulation Drug Registration
China Provisionally Extends Deadlines for Submitting Drug Registration Applications' Supplemental Documents On Oct. 14, 2022, China National Medical Products Administration (NMPA) announced it would temporarily extend the deadlines for drug registration applicants to submit supplemental documents. If finding applications deficient, NMPA will issue deficiency letters that require relevant applicants to submit supplemental documents.
Oct 19, 2022
INDUSTRY
Innovative Drug Generic Drug Inhalation Respiratory Disease
China Inhalation Drug Market: Nearly 5 Billion USD in 2021 and Still Growing China is a huge inhalation drug market, whose value reached 35.48 billion yuan in 2021. The market shows two trends: 1. Though nebulizers take the highest market share, dry powder inhalers and metered-dose inhalers' shares are expected to increase. 2. Overseas inhalation drugs account for the most shares, while Chinese generics seek to improve shares via volume-based procurement.
Oct 17, 2022
REGULATION
Law & Regulation Clinical Trial Post-market OTC Drug
China Updates Documentation Requirements for Rx-to-OTC Switch Applications China no longer requires drug quality and efficacy research documents for Rx-to-OTC switch applications. Besides, China gives more detailed specifications under each required document item.
Oct 10, 2022
INDUSTRY
Marketing Approval Priority Review and Approval Innovative Drug Generic Drug Biological Product Cancer Diabetes Drug Registration New Drug
Monthly Report: New Drug Approvals in China | September 2022 In September 2022, China NMPA approved 16 new drugs, including 12 chemical drugs and 4 biological products.
Oct 08, 2022
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