The Philippine Food and Drug Administration (FDA) is seeking feedback on draft guidance for its transition to new medical device rules.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”
Category: Regulation
Regulatory news and updates
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”
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”
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”
The future of UK clinical research delivery
The United Kingdom (UK) government has released a policy paper detailing its vision for the future of clinical research in the UK. Read more “The future of UK clinical research delivery”
Health Canada’s guidance on electronic media in prescription drug labelling
In response to sponsors seeking authorisation to add extra information to prescription drug labels, Health Canada has released a draft guidance document detailing the agencies expectations on the use of electronic platforms to disseminate information on a prescription drug product. Read more “Health Canada’s guidance on electronic media in prescription drug labelling”
Updated EMA and EUnetHTA advice on parallel consultation
The European Network for Health Technology Assessment (EUnetHTA) was initially set up in 2017 to enable a simplified procedure for obtaining joint scientific advice from the European Medicines Agency (EMA) and Health Technology Assessment (HTA) bodies. Read more “Updated EMA and EUnetHTA advice on parallel consultation”