Regulatory Blog

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...

To legally sell or supply an Advanced Therapy Medicinal Product (ATMP) in the United Kingdom, you must obtain a marketing authorisation...

The Medicines and Healthcare Products Regulatory Agency (MHRA)  oversees the regulation and registration of medical devices within the...

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance on Software and Artificial Intelligence (AI) as a...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on " Clinical trials for medicines: manage...

The Medicines and Healthcare Products Regulatory Agency (MHRA) has released updated guidance on pharmacovigilance requirements that...

The Medicines and Healthcare products Regulatory Agency (MHRA) has recently initiated a public consultation on draft guidance for "...

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued several guidance documents detailing the licensing,...