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News, Views, Blogs, Podcasts, Webinars & Opinion Pieces
The International Recognition Framework – our view
On 26th May 2023, the MHRA released further details on the International Recognition Procedure....
PRIME: PRIority MEdicines – An Update
What is PRIME (priority medicines)? PRIME (priority medicines) is a scheme launched by the...
Boosting development of children’s medicines
For as long as I can remember in my pharma career, there have always been challenges in enabling...
The Windsor Framework
We can’t issue a Regulatory newsletter without referencing The Windsor Framework, can we! On 28th...
MHRA new International Framework
We all know about the European Commission Decision Reliance Procedure (ECDRP) and that it has been...
Who the heck are Fusion Pharma anyway?
Who the heck are Fusion Pharma anyway? We are a wonderful bunch of Regulatory Affairs experts!!...
ILAP TDP Toolkit
To conclude my new 2023 blog series on the Innovative Licensing and Access Pathway (ILAP), in this...
ILAP Target Development Profile
As part of my 2023 series on the Innovative Licensing and Access Pathway (ILAP), in this blog we...
ILAP Innovation Passport
As I was refreshing my original Innovative Licensing and Access Pathway (ILAP) blog, I realised...
ILAP Revisited
I first wrote about the Innovative Licensing and Access Pathway (ILAP) in 2021 shortly after it...
Clinical Trial Regulation (CTR) – A Closer Look
Clinical Trial Regulation (CTR) From 31st January 2023, it will no longer be possible to...
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...
Scientific Advice Meetings with the MHRA
Why might I need a Scientific Advice Meeting? Do you have a questions for the Medicines and...
NIMAR vs Specials
NIMAR vs Specials Following on from my other blogs on NIMAR (Northern Ireland MHRA Authorised...
NIMAR – A Closer Look
NIMAR - A Closer Look Following on from my original blog titled 'An Introduction to NIMAR', today...
An Introduction to the Northern Ireland MHRA Authorised Route (NIMAR)
An introduction to the Northern Ireland MHRA Authorised Route (NIMAR) What is the...
MHRA Active Substance Registrations
Today's blog will help you navigate registrations for Active Pharmaceutical Ingredients (API),...
MHRA Wholesaler Dealer’s Licence (WDA(H))
Do you need a Wholesale Dealer's Licence (WDA(H)) to conduct your business in the UK? If so, our...
MHRA Manufacturer’s Licence (MIA)
To manufacture, assemble or import medicinal products for human use, you need a Manufacturer's...
Paediatric Investigation Plans (PIPs) in the UK
Today we visit the topic of Paediatric Investigation Plans (PIPs) and all related submissions to...
Paediatric Investigation Plans (PIPs) in the EU
Today I'm writing a short blog to introduce Paediatric Investigation Plan (PIP) submissions to the...
PRIME: PRIority MEdicines
In today's blog I will be taking a look at PRIME (priority medicines), a scheme launched by the...
SME status in the UK
Are you a small or medium-sized enterprise (SME)? If so the Medicines and Healthcare Products...
SME status in the EU
Are you a small or medium-sized enterprise (SME) established in the European Union (EU)/ European...
Clinical Trials Regulation in the EU
Clinical Trials Regulation in the EU The Clinical Trials Regulation (Regulation (EU) No...
Combined Review
Today we are looking at the combined review service; from 1 January 2022 all new Clinical Trials...
PSURs/PBRERs – UK Processing
UK processing of PSURs/ PBRERs Today we are concluding our foray into the topic of Periodic Safety...
International Expansion
We welcome Sue Allen, Senior Regulatory Affairs Consultant, to discuss the practical...
PSURs/PBRERs – EU Processing
EU processing of PSURs/ PBRERs Today we are focusing on the processing of Periodic Safety Update...
Fusion Chat
We are delighted to share the next instalment of our Fusion Chat series with our latest member of...
Compliance Culture
It is our pleasure to introduce Julie Yeoman as one of our guest bloggers, who writes so...
Preparation of PSURs/PBRERs
How to prepare your PSURs/ PBRERs Today we are continuing our series on PSURs and PBRERs by...
An Introduction to PSURs and PBRERs
An introduction to PSURs and PBRERs Today I am introducing Periodic Safety Update Reports (PSURs)/...
Fusion Chat
We are delighted to host Dr Donna Lockhart within our Fusion Chat series, interviewed by Leah...
Early Access to Medicines Scheme
The early access to medicines scheme (EAMS) was introduced by the MHRA with the objective of...
Brexit – CAP Renewals
Today we're looking at renewals submitted for Marketing Authorisations (MAs) granted through the...
The Importance of Cross-functional Working – a Marketing Perspective
We are delighted to introduce Michelle Bridgman who brings along with her 10 years of experience...
Renewals – The Basics
Dr Marsh answers a few fundamental questions on licence renewals, with a UK slant. For how...
Fusion Chat
This month we speak with Dr. Lorraine Marsh, Head of Scientific Affairs at Fusion Pharma, about...
Fusion Chat
This week we are in conversation with Fusion Pharma’s Founder and Managing Director, Leah...
ILAP – Innovative Licensing and Access Pathway
Today we are focusing on the Innovative Licensing and Access Pathway (ILAP). What is the ILAP? The...
Regulatory Intelligence
Here we introduce a topic that can be seen as somewhat onerous, however it is vital for the...
Project Orbis
Today we are focusing on the Project Orbis initiative, with a UK slant. What is Project...
Charity in the workplace
Giving to charity is a very personal choice, usually influenced by experience, values and...
Access Consortium
Today we're focusing on the Access Consortium. The trend towards globalisation of therapeutic...
Brexit – Impact of COVID-19
On 23 June 2016, the United Kingdom narrowly voted to leave the European Union, a decision which...
COVID-19 – Impact on Hospital Patients
In response to the COVID-19 pandemic, and to prevent the NHS being overwhelmed due to a rapid...
Quality and manufacturing strategy during product development planning
During 30 years' experience in medicines and device development it has been my observation that...
Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs)
Parallel Distribution Notices (PDNs) are no longer valid in Great Britain (England, Scotland,...
Brexit – Unfettered Access Procedure (UAP)
What is the Unfettered Access Procedure (UAP)? Applicants may seek recognition in Great Britain of...
Brexit – Packaging
Registering new packaging information for medicines Once you have been issued with your new...
Brexit – MAH & QPPV Location
Marketing Authorisation Holder (MAH) and Qualified Person for Pharmacovigilance (QPPV) location...
Brexit – Routes to obtaining an MA in UK/ NI/ GB
There are now several routes to obtaining a Marketing Authorisation (MA) in the UK, Great Britain...
Parallel Import Scheme
What is the UK parallel import licensing scheme? The UK parallel import licensing scheme lets a...
Brexit – MRP/ DCP Renewals
Today we're looking at Renewals submitted for Marketing Authorisations (MAs) granted through...
Brexit – Variations
Now that the Brexit transition has taken place you may be wondering what your options are for...
Brexit – Centralised Procedure
Today we'll be looking at how licences authorised via the EU centralised procedure are going to be...
MHRA – Exemptions from Devices regulations during COVID-19 pandemic
You may be able to get exemptions from certain regulations for your medical device during the...
COVID-19 – Regulators respond – Australia, New Zealand Focus
Yesterday we looked at the response from the authorities in Middle East & Latin...
COVID-19 – Regulators respond – Middle East & Latin America Focus
Yesterday we looked at the response from the authorities in India (COVID-19 - Regulators Respond...
COVID-19 – Regulators respond – India Focus
My last mini blog focused on the USA agency response (COVID-19 - Regulators Respond - USA Focus),...
COVID-19 – Regulators respond – USA Focus
Last time we looked at the MHRA response (COVID-19 - Regulators Respond - UK Focus), today we...
COVID-19 – Regulators respond – UK Focus
Many aspects of our lives have been affected by the pandemic which has seen cases and deaths...
COVID-19 – Regulators respond – EU Focus
Today we're looking at how regulatory authorities around the world are responding to the COVID-19...
PDF licences and certificates from MHRA
Staff at the MHRA are working from home so they are issuing electronic pdf copies of licences and...