Regulatory Blog

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...

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has updated the Appendix 4 Best Practice Guidance of the " Blue Guide:...

The Medicines and Healthcare products Regulatory Agency (MHRA) has established guidelines " Medicines: Register to manufacture, import...

The Medicines and Healthcare Products Regulatory Agency (MHRA) has released updated guidance on " Good Clinical Practice (GCP) for...

Earlier today the Medicines and Healthcare products Regulatory Agency (MHRA) released updated guidance " Register medical devices to...