MHRA RegulatoryConnect Portal
Last week the Medicines and Healthcare products Regulatory Agency (MHRA) held a webinar for the launch of the new MHRA RegulatoryConnect Portal that is due to be released at the end of March. So what is the aim of the new MHRA RegulatoryConnect Portal? The aim of the RegulatoryConnect Portal is to allow for greater […]
MHRA Notification Scheme
The UK Clinical Trial sector is due to benefit from a recently launched MHRA notification scheme for certain types of initial Clinical Trial Applications (CTAs). This marks the start of an MHRA overhaul of UK clinical trial regulations. The scheme will see the lowest-risk clinical trials processed in less than 14 days (reduced from 30 […]
The Consequences of Poor Regulatory Affairs Performance: A Comprehensive Guide
Introduction In the dynamic landscape of the pharmaceutical industry, effective management of regulatory affairs is crucial for ensuring the safety, efficacy, and timely market access of pharmaceutical products. However, subpar performance in regulatory affairs can have far-reaching consequences. In this comprehensive guide I will explore the significant implications that stem from poor regulatory affairs management. […]
PRIME: PRIority MEdicines – An Update
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. What is the update regarding PRIME? The EMA published a report presenting results from the first five years of […]
ILAP TDP Toolkit
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 Target Development Profile roadmap you will start making use of the […]
ILAP Target Development Profile
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 the Pathway and the road map called the […]
ILAP Innovation Passport
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 this blog is on the Innovation Passport. The Innovation […]
ILAP Revisited
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 we have learnt so far. To recap: ILAP is a pathway […]
Clinical Trial Regulation (CTR) – A Closer Look
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 approved under the Directive without first transitioning to the new Clinical Trial […]
Clinical Trials in the EU – CTIS
How do you submit initial Clinical Trials in the EU? In January 2022 I wrote a blog about the new Clinical Trial Regulation (CTR) and the Clinical Trials Information System (CTIS) and now as of 31st January 2023 clinical trial sponsors will need to use CTIS to apply to start a new clinical trial in […]