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PRIME: PRIority MEdicines – An Update

PRIME: PRIority MEdicines – An Update

by Nosheen Majid | Apr 20, 2023 | News, Regulatory Affairs, Regulatory Intelligence

What is PRIME (priority medicines)? PRIME (priority medicines) is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. My previous blog introducing PRIME can be found here....
ILAP TDP Toolkit

ILAP TDP Toolkit

by Dr Lorraine Marsh | Feb 27, 2023 | News, Regulatory Affairs, Regulatory Intelligence

To conclude my new 2023 blog series on the Innovative Licensing and Access Pathway (ILAP), in this blog I’m going to touch on the Target Development Profile (TDP) Toolkit aspect of ILAP. Once you have your Innovation Passport (IP) and are working through your...
ILAP Target Development Profile

ILAP Target Development Profile

by Dr Lorraine Marsh | Feb 27, 2023 | News, Regulatory Affairs, Regulatory Intelligence

As part of my 2023 series on the Innovative Licensing and Access Pathway (ILAP), in this blog we are going to explore the Target Development Profile (TDP) aspect of ILAP.   Once you have your Innovation Passport (IP) (see my earlier blog) you then have access to...
ILAP Innovation Passport

ILAP Innovation Passport

by Dr Lorraine Marsh | Feb 27, 2023 | News, Regulatory Affairs, Regulatory Intelligence

As I was refreshing my original Innovative Licensing and Access Pathway (ILAP) blog, I realised just how much there was to unpack about this process. So I’ve decided to break it down into more manageable chunks and explore each aspect a bit more. The focus of...
ILAP Revisited

ILAP Revisited

by Dr Lorraine Marsh | Feb 27, 2023 | News, Regulatory Affairs, Regulatory Intelligence

I first wrote about the Innovative Licensing and Access Pathway (ILAP) in 2021 shortly after it had initially been published on the Medicines and Healthcare products Regulatory Agency (MHRA) website. In a series of short blogs I shall unpack what is involved and what...
Clinical Trial Regulation (CTR) – A Closer Look

Clinical Trial Regulation (CTR) – A Closer Look

by Rob Heathman | Feb 1, 2023 | News, Regulatory Affairs, Regulatory Intelligence

Clinical Trial Regulation (CTR)   From 31st January 2023, it will no longer be possible to submit new initial clinical trial applications under the Clinical Trials Directive.  It will also no longer be possible to add new Member States (MS) to existing trials...
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