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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
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
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
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
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
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
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