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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
INDUSTRY
MAH Marketing Approval Priority Review and Approval Innovative Drug Generic Drug Biological Product Diabetes Rare Disease Drug Registration New Drug
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
Law & Regulation Pharmacopoeia CMC Clinical Trial API Gene Therapy New Drug
Understanding 42 Guidelines in the Chinese Pharmacopoeia The Chinese Pharmacopoeia 2020 Edition includes 361 general chapters, including 38 general requirements for preparations, 281 testing methods and other general chapters, and 42 guidelines.
Aug 30, 2022
REGULATION
GMP Post-market Volume-Based Procurement
China Suspends UCB's Antiepileptic Drug, Keppra, from Import, Sale, and Use On Aug. 24, China NMPA suspended the import, sale, and use of UCB Pharma S.A.’s Levetiracetam Concentrated Solution for Injection (Keppra), a drug for epilepsy treatment.
Aug 26, 2022
REGULATION
Law & Regulation GMP CMC The US
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
Priority Review and Approval Innovative Drug Rare Disease Drug Registration New Drug
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
REGULATION
Pharmacovigilance The UK
UK Changes SUSAR Reporting for IMPs The eSUSAR website used for the submission of SUSAR reports to the MHRA will be decommissioned at the end of September and only SUSARs via the ICSR Submissions portal will then be accepted.
Aug 16, 2022
INDUSTRY
Biological Product New Drug
China's Growth Hormone Treatment Market Is Booming In 2018, China's growth hormone market size was 0.6 billion USD. With an estimated CAGR of 15.7% from 2018 to 2030, the market size is expected to reach 3.2 billion USD by 2030.
Aug 15, 2022
INDUSTRY
New Drug COVID-19
China's First Homegrown COVID-19 Pill, Azvudine, is Priced at 270 Yuan Per Bottle China's first domestic oral drugs for COVID-19 treatment, Genuine Biotech's Azuvidine Tablets, is priced at no more than 300 yuan for each bottle, which contains 35 tablets (1mg/tablet). The recommended dosage is 5 mg (five 1mg tablets) per day for a course no longer than 14 days. Thus, a course of Azvudine costs no more than 600 yuan.
Aug 12, 2022
INDUSTRY
Volume-Based Procurement Diabetes
How China's Volume-based Procurements (VBPs) Impact Diabetes Medicine Market A total of 27 diabetes drugs, including Empagliflozin, Canagliflozin, and Glipizide, have entered China's national volume-based procurements (VBPs).
Aug 11, 2022
REGULATION
Law & Regulation CDE Guideline Pharmacopoeia Reference Listed Drug (RLD) OTC Drug Vaccine
Monthly Recap: China Pharmaceutical Regulatory Updates | July 2022 Check out the pharma regulatory updates in China: The 7th National Volume-based Procurement (VBP) Includes 327 Drug Products; China CDE Consults on Procedures for Starting For-cause Inspections; China CDE Releases Q&A on Immediate Report of Adverse Drug Reactions in Clinical Trials...
Aug 05, 2022
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