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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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 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
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
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
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
REGULATION
Pharmacopoeia EU
EDQM: European Pharmacopoeia Version 11 Published The 11th version of the European Pharmacopoeia (Ph.Eur.) is now available. The latest edition comprises some updated monographs which will be implemented on 01 January 2023.
Jul 22, 2022
REGULATION
Pharmacopoeia Packaging
Chinese Pharmacopoeia Commission Consults on 46 Packaging Material Standards Since June 10, 2022, the Chinese Pharmacopoeia Commission has issued the drafts of 46 pharmaceutical packaging standards according to the plan for compiling the Chinese Pharmacopoeia 2025 Edition. The Commission is currently collecting public advice and comments on the drafts until Sept 1, 2022.
Jul 21, 2022
REGULATION
Law & Regulation Pharmacopoeia Excipient
Chinese Pharmacopoeia Commission Seeks Public Advice on Colorant Standards The Chinese Pharmacopoeia Commission is currently asking for public advice on colorant standards. The target colorants include but are not limited to colorants used in pediatric drugs, or widely used in pharmaceuticals, or whose current quality control standards are incomplete, especially for operation, and whose current standards cannot meet the need for medical use.
Jul 18, 2022
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