MHRA
Regulatory Sciences
August 7, 2023
International Recognition Framework (IRF): Are You Ready?
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new international recognition framework (IRF) for medicines and devices. The IRF will be in place from January 1st,...
MHRA
UK
March 27, 2023
The Future of UK Clinical Research Delivery
ProPharma applauds the myriad of recent, positive developments for clinical trials in the UK, representing the biggest overhaul in UK clinical trials in two decades. Lord O’Shaughnessy Clinical Trial...
PDP
PMA
August 9, 2022
From Idea to Market: The Five Stages of Product Development
From Idea to Market: The Five Stages of Product Development. The exact product development process for medical devices differs from region to region, with different regulatory expectations that need...
FDA
MHRA
August 8, 2022
Early engagement with Health Technology Assessment authorities will accelerate product launch and improve chances for reimbursement
Pharmaceutical companies should understand EU Health Technology Assessment (HTA) authorities requirements early in the product development phase. Engagement with HTA authorities during clinical...
MHRA
North America
August 1, 2022
UK Paediatric Investigational Plans – what do you need to know?? …and how is it all working in practice??
If a marketing authorisation is planned to be submitted in England, Scotland, and Wales (GB), an MHRA-approved paediatric investigational plan (PIP) is required. Up until January 1, 2021, PIPs were...
MHRA
ICH GCP
September 9, 2021
How to Implement an Effective Audit Trail
Maintaining an audit trail is a regulatory compliance requirement, but what makes an audit trail beneficial for maintaining effectiveness and complying with regulations? This blog will explain what...