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 […]

Scientific Advice Meetings with the MHRA

Why might I need a Scientific Advice Meeting? Do you have a questions for the Medicines and Healthcare products Regulatory Agency (MHRA) about the development of your medicine, a Marketing Authorisation Application (MAA) or a variation?  Then you may benefit from a scientific advice meeting with the MHRA.  Our blog provides an outline of where […]

NIMAR vs Specials

NIMAR vs Specials Following on from my other blogs on NIMAR (Northern Ireland MHRA Authorised Route) I have been asked about Specials. What is the difference between NIMAR medicines and Specials? We need to be careful to distinguish between supply under the NIMAR route and Regulation 167, which is the Specials Route: Specials are unlicenced […]

NIMAR – A Closer Look

NIMAR – A Closer Look Following on from my original blog titled ‘An Introduction to NIMAR‘, today we shall have a look in more detail, particularly focussing on Distribution of NIMAR medicines to Northern Ireland Advertising and promotion of medicines on the NIMAR list How are these products supplied to Northern Ireland via NIMAR? GB-based […]

An Introduction to the Northern Ireland MHRA Authorised Route (NIMAR)

An introduction to the Northern Ireland MHRA Authorised Route (NIMAR)   What is the background to NIMAR? Following Brexit the UK Government brought in a new supply route, NIMAR, to ensure that prescription only medicines (POMs) are available to Northern Ireland (NI). What are the criteria for going down the NIMAR route? There must be […]

MHRA Active Substance Registrations

Today’s blog will help you navigate registrations for Active Pharmaceutical Ingredients (API), sometimes referred to as the ‘Drug Substance’. If you manufacture, import or distribute API(s) and you are based in the UK you must register with the Medicines and Healthcare Products Regulatory Agency (MHRA). A flow chart is available to help you decide which […]