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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 | 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
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Monthly Report: New Drug Approvals in China | August 2022
In August 2022, China NMPA approved 13 new drugs, including 9 chemical drugs and 4 biological products. Among them, MSD's HPV 9-valent vaccine got approval to expand the target group from females 16-26 years of age to 9-45 years of age.
Sep 09, 2022
REGULATION
CMC: FDA Publishes Guideline With Questions on Post-approval Modification of Single-use Materials
With the publication of a question and answer guideline, the FDA is responding to the challenges of the shortage of disposable materials in manufacturing and the requirements for the use of alternative materials in the area of chemistry, manufacturing and controls (CMC).
Aug 19, 2022
INDUSTRY
China CDE to Grant Priority Review Designation to Sanofi's Avaglucosidase Alfa, a Rare Disease Therapy
Sanofi's avalglucosidase alfa entered the preliminary list of priority review designation on August 15, as shown on China CDE's website. If no objections are filed to CDE by August 22, the drug will officially be granted the priority review and can complete the technical review within 70 workdays, much shorter than 200 workdays for drugs without the priority review.
Aug 18, 2022
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