A link to the newly published ICMRA paper, which provides a valuable insight into how global regulators have managed regulatory oversight, inspections and assessments during the pandemic to support both the COVID-19 response, and also ‘business as usual’ GMP and GCP inspections.
The use of automation in healthcare is helping transform how patient care is delivered and robotic dispensing systems and barcode verification are now widespread amongst pharmacy operations across both primary and secondary environments, aiming to reduce human error and improve …
In six months’ time, on 28 April 2026, the most significant update to UK clinical trials regulations in two decades will come into force. This will be a pivotal moment for the evolving clinical trial landscape and marks a new …
September 2025: This blog provides information about the Route B substantial modifications and why you should sign up to take part in the pilot if you are eligible. We developed new clinical trial legislation in collaboration with the Health Research …
Decentralised Manufacturing (DM) is the overarching term used in the UK to cover the two elements of the new manufacturing and supply framework: point of care (POC) and modular manufacturing (MM). A cross-agency team of Quality and Clinical Trial assessors, …
This Blog relates to actions which licence holders should do following the issuing of USFDA Warning Letters. The MHRA’s Inspection Action Groups (IAG) are responsible for recommending and implementing regulatory action against companies for breaches across all GxPs, and its …
The aviation and marine sectors are a journey away from the traditional scope of a Wholesale Dealer’s Licence (WDA(H)), and one of unique and specific challenges. The lorries and trucks that supply medicines to hospitals and pharmacies also head to …
In March of this year, a letter was sent to Manufacturer’s “Specials” (MS) Licence holders who were involved in the manufacture of sterile products. An overview of unlicenced medicines guidance is provided here: Supply unlicensed medicinal products (specials) This was …
The purpose of this blog is to describe our approach to the validity date of UK issued certificates confirming compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). Following the end of the COVID-19 public health emergency declared …
Come and join the next MHRA Symposia in February 2025 and hear the latest on Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) in the UK from MHRA inspectors and regulators. Registration is available on the dedicated symposia website for in-person …
As a GCP Inspector at the UK Medicines and Healthcare products Regulatory Agency (MHRA), I thought it would be useful to inform you that Annex 2 of the International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Guideline has …
