How far can you push your supplement claims?

How far can you push your supplement claims before it becomes a medicine? The UK supplement industry is booming – from wellness influencers to high-street brands, everyone seems to be selling vitamins, minerals, and herbal blends promising things such as better sleep, energy, and immunity. But how far can you push those claims before you […]

MHRA Borderline Medicines Department

Understanding the MHRA Borderline Medicines Department: Protecting Public Health and Clarifying Product Classification In the complex world of consumer healthcare products, there is often a fine line between what constitutes a medicine, a cosmetic, a food supplement, or a medical device. This is where the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) Borderline Medicines […]

Traditional Herbal Registration vs Food Supplement

Why register your product as a traditional herbal registration instead of a food supplement? Herbal products are available in various forms on the UK market. They can be a licensed medicine – either with a full standalone license or alternatively as a ‘traditional herbal medicine’. In the UK the traditional herbal registration (THR) scheme allows […]

Active Substance Master File procedure in the UK

What is an active substance master file? An active substance master file (ASMF) is a great way for an active substance manufacturer to retain confidential intellectual property on a substance, while still providing enough information to the marketing authorisation holder (MAH) to take full responsibility over their medicine. The format is based on the eCTD, […]

Artificial Intelligence (AI) in Pharma

Artificial Intelligence (AI) isn’t just a concept of the future – it’s a pervasive force shaping our everyday lives. From the personalized recommendations on streaming platforms to the targeted ads that pop up in our social media feeds, AI algorithms silently influence our choices. It powers virtual assistants, streamlines customer service interactions, and optimizes supply […]

How Artificial Intelligence is advancing the pharmaceutical industry

Artificial intelligence (AI) has emerged as a game-changer for the pharmaceutical industry, revolutionising drug discovery, development and personalised medicine. With its ability to analyse vast amounts of complex data and patterns in a way we have never been able to do before, AI is facilitating advancements in various aspects of the industry. Drug Discovery One […]

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 […]