The Nitrosamine Implementation Oversight Group (NIOG) was set up by the European medicines regulatory network (EMRN) to oversee the harmonised implementation of the CHMP opinion on nitrosamines in human medicinal products. Read more “EMA’s Nitrosamine Implementation Oversight Group”
Year: 2021
New medical device rules in the Philippines
The Philippine Food and Drug Administration (FDA) is seeking feedback on draft guidance for its transition to new medical device rules. Read more “New medical device rules in the Philippines”
EC update on how to ensure a successful transition to the incoming device regulations
The European Commission (EC) has recently released updates aimed at ensuring all stakeholders are prepared for the transition to the European Union (EU) In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR). Read more “EC update on how to ensure a successful transition to the incoming device regulations”
Key changes to UK amendment process for clinical trials
The Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have implemented two changes to the UK amendment process for clinical trials from 25 March 2021. Read more “Key changes to UK amendment process for clinical trials”
A summary of recent TGA regulatory updates
As Australia continues to improve its regulatory framework, the Therapeutic Goods Administration (TGA) has regularly released new and updated materials concerning the regulation of both medicines and devices. A summary of the recent updates are provided below. Read more “A summary of recent TGA regulatory updates”
Q&A guidance from the FDA on generic drug development during COVID-19
The US Food and Drug Administration (FDA) has published a Q&A guidance concerning abbreviated new drug application (ANDA) submissions during the COVID-19 pandemic. Read more “Q&A guidance from the FDA on generic drug development during COVID-19”
European Commission initiative to revamp pharmaceutical legislation
In November 2020, the European Commission (EC) adopted its Pharmaceutical Strategy for Europe in which one commitment was to conduct a review of its pharmaceutical legislation. The EC has now released a roadmap outlining how it plans to deliver this regulatory overhaul. Read more “European Commission initiative to revamp pharmaceutical legislation”
Detailed guidance on the Target Development Profile Toolkit
When the Innovative Licensing and Access Pathway (ILAP) was launched at the start of 2021, it was announced that the Target Development Profile (TDP) will be available to applicants to support their application through this pathway. Read more “Detailed guidance on the Target Development Profile Toolkit”
MHRA advice on responding to GLP and GCP inspection reports
The Medicines and Healthcare products Regulatory Authority (MHRA) has released guidance for industry on preparing responses to good laboratory practice (GLP) and good clinical practice (GCP) inspection reports. Read more “MHRA advice on responding to GLP and GCP inspection reports”
HPRA announces Clinical Trials Regulation-National Collaboration Project
Ireland’s Health Products Regulatory Authority (HPRA) has launched the Clinical Trials Regulation-National Collaboration Project (CTR-NCP). Read more “HPRA announces Clinical Trials Regulation-National Collaboration Project”