ILAP Relaunched
I first wrote about the Innovative Licensing and Access Pathway (ILAP) back in 2021 (and again in 2023) so many of you will be familiar with terms such as Innovation Passport (IP), Target Development Profile (TDP) and TDP Toolkit. Over the last few years significant experience of the pathway has shown that the process can […]
Variations Guidelines Updates
Changes to the Variations Regulation When I think about Lifecyle management, once the MAA is obtained, what springs to my mind is variations, variations, variations. They are never ending and new challenges are always arising. Be it a change to a Marketing Authorisation Holder name, change to the packaging or change to an excipient, these […]
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. […]
Traditional Herbal Registrations
Traditional herbal registrations Following on from my previous blog introducing herbal medicinal products (which you can find here), this blog is going to look deeper into the traditional herbal registration (THR) pathway and how it can be used. What is the traditional herbal registration pathway? In 2004 the EU and UK introduced a simplified […]
Regulating Herbal Medicines in the UK and EU
Regulating herbal medicines in the UK and EU What is a herbal medicine? Herbal medicinal products are those which contain exclusively herbal substances or herbal preparations (or a combination of the two) as active ingredients. The European directive 2001/83/EC describes a herbal substance as ‘whole, fragmented or cut plants, plant parts, algae, fungi, lichen […]
International Recognition Framework – An Opinion Piece
On 26th May 2023, the MHRA released further details on the International Recognition Procedure. This was first announced in January in anticipation of what would replace the existing ‘Reliance Procedure’ (due to end Dec 2023), a post-brexit route to allow UK/GB to recognise the assessment of the EMA/EU. We are likely to hear more about […]
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 […]