Regulatory Blog

In an era of rapid pharmaceutical innovation, global collaboration is key to expediting patient access to new therapies. To help patients...

The regulatory landscape for medical devices and digital health technologies in the UK is evolving rapidly, reflecting the growing...

Clinical trials are the cornerstone of modern medicine, ensuring that new treatments are safe, effective, and suitable for public use....

The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has launched Phase 2 of its AI Airlock programme , supported by a...

In the ever-evolving landscape of medical device regulation, the Periodic Safety Update Report (PSUR)   plays a pivotal role in ensuring...

In recent years, the MHRA has issued several key guidance documents strengthening the lifecycle safety and regulatory oversight of...

Navigating the regulatory landscape for medicines in the UK can be complex, especially as requirements evolve and innovation accelerates....

The Medicines and Healthcare products Regulatory Agency (MHRA) published a key update on 17 June 2025 , outlining revised requirements...

The post-Brexit regulatory landscape for medical devices in the UK has brought significant changes, particularly in Northern Ireland,...

In recent years, GLP-1 receptor agonists have gained widespread attention for their dual role in type 2 diabetes management and weight...

In the evolving landscape of pharmaceutical manufacturing, Decentralised Manufacture  has emerged as a pivotal approach, especially in...

Understanding and navigating the UK's regulatory requirements is crucial for pharmaceutical companies aiming to obtain marketing...

In a globally interconnected pharmaceutical landscape, regulatory collaboration is essential to ensure timely patient access to safe and...

In a regulatory landscape that continually evolves to ensure public health and safety, the UK Medicines and Healthcare products...

The Medicines and Healthcare products Regulatory Agency (MHRA) has published updated guidance on " The Northern Ireland MHRA Authorised...

The Medicines and Healthcare products Regulatory Agency (MHRA) has published updated guidance on " Risk Minimisation Measures (RMMs) for...

Before starting any clinical investigation involving a medical device in the UK, it is a legal requirement to notify the Medicines and...

The Medicines and Healthcare Products Regulatory Agency (MHRA) has introduced a " National Assessment Procedure for Medicines "  for...

Ensuring the ongoing safety and efficacy of medicinal products is a cornerstone of pharmacovigilance. In the United Kingdom, the...

The regulatory landscape for pharmaceuticals is constantly evolving, and the UK Medicines and Healthcare products Regulatory Agency...