Sep 4, 20181 min read

Drugs - Aug/Sep 2018

International - ICH Guidelines Implementation
Australia - Medical Devices Safety Update, Volume 6, Number 4, Jul-2018
China - CDE Notification on Issuance of the General Requirements for the Production Scales of Generic Drug Registration Batches (Trial)
Japan - Notice: PSEHB/PED: Q&A on Guideline of Drug Interactions for Pharmaceutical Development and Information Provision, 23-Jul-2018
Canada - Notice of Compliance Information for Medicinal Products (NOC), Jun-2018
European Union - Pediatric Decision History: PALEXIA and Associated Names, YANTIL and Associated Names and TAPENTADOL and Associated Names (tapentadol (hydrochloride))
European Union - Pediatric Decision History: dopamine
United Kingdom - MHRA: Guidance Note No. 8: A Guide to What is a Medicinal Product
United Kingdom - United Kingdom - MHRA: A Consultation on Implementing ‘Safety Features’ under the Falsified Medicines Directive
Brazil - Medical Devices Regulatory Framework
Saudi Arabia - MDS-G26: Guidance of Requirements for Preliminary Products Importation for the Purpose of Local Manufacturing of Medical Devices, Version 1.0
USA - Federal Register: Facilitating Competition and Innovation in the Biological Products Marketplace; Public Hearing; Request for comments
USA - Federal Register: Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases; Guidance for Industry; Availability (Notice of availability)

Recent Posts