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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
INDUSTRY
Priority Review 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 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 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
INDUSTRY
Marketing Approval Priority Review Innovative Drug Generic Drug Biological Product Drug Registration New Drug COVID-19
Monthly Report: New Drug Approvals in China | July 2022 In July 2022, China NMPA approved 10 new drugs, including 8 chemical drugs and 2 biological products. Among the drugs, Genuine Biotech's Azvudine Tablets is the first homegrown oral drug to get NMPA’s approval for COVID-19 treatment.
Aug 05, 2022
REGULATION
Law & Regulation Turkey
The Turkish Pharmaceutical Industry's Regulatory Landscape This article introduces the general organizational and regulatory landscape of the pharmaceutical industry in Turkey in terms of licensing, advertising and promotion, pricing & reimbursement, data privacy, and competition.
Aug 03, 2022
REGULATION
Law & Regulation EU US Turkey
Medical Use of Cannabis and Legal Approach This article introduces the usage and legislation of cannabis in the US, EU, and Turkey.
Aug 03, 2022
REGULATION
MAH
Key Points for Manufacturing Entrustment Under China's Marketing Authorization Holder (MAH) System China's drug marketing authorization holder (MAH) system was first piloted in China in 2015 and officially implemented in 2019. It allows MAHs to entrust manufacturing activities to other companies.
Jul 29, 2022
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