United States withdraws from World Health Organisation
The World Health Organisation (WHO) is an agency within the structure of the United Nations (UN), formed in 1948 to coordinate international efforts to tackle global physical, mental and social health challenges and emergencies. With the withdrawal of the United States from this structure on 22 January 2026, and Argentina confirming their intention to follow, […]
MHRA Meeting Types
As part of their commitment to providing access to safe and effective medicines in the UK, the MHRA offer a variety of meeting options for Marketing Authorisation Holders and medicine developers to assist in bringing new products to the market. This blog looks at three of the most important types of meeting and how they […]
Medicine Repurposing and Line Extensions
What is medicine repurposing? Some medicinal products have been found to have therapeutic uses outside of their licensed indication(s) and/or instructions for use. While this undoubtedly provides a benefit to patients, a legal issue remains over the off-licence use of medicines. Repurposing moves the newly discovered off-label use to be on-label, so the medicine becomes […]
EU Pharmaceutical Legislation Reform Proposals
What is the EU pharmaceutical legislation reform? The EU has been formulating a total redrafting of its pharmaceutical legislation framework since it published its roadmap in March 2021. The general approach was agreed by the council in June 2025. This reform (or “pharma package”) aims to produce two key documents: A Regulation to incorporate and […]
UK Generics – Variations
This blog summarises two common examples of safety variations performed on generic licences: Authority-driven safety updates (e.g. PRAC recommendations, MHRA requests), and Reference product updates. Authority-driven safety updates requiring a variation Scientific bodies such as the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Medicinal Products in Human use (CHMP) release new recommendations to […]
UK Generics – How to compare your product information to a reference product
What is a reference product? A reference product is an innovator Marketing Authorisation (MA) that is periodically referred to when updating the safety information in a generic licence. The chosen reference product forms part of the basis for a generic licence to be granted by the competent authority. Which products use a reference? Many generic […]
Decentralised Manufacturing
What is Decentralised Manufacturing (DM)? DM brings a new manufacturing model to the pharmaceutical industry whereby a central site supervises and controls one or more ‘decentralised’ sites located close to patients. These sites can perform various manufacturing and testing functions via two distinct routes: Point of Care (POC): products that are made near the patients, […]