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.
By Anthony Carter – MHRA Low-Risk Assessor Manager, Clinical Investigations & Trials Operations Team 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 …
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 …
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 …
February 2025: We have updated some details in this blog post to reflect changes to the payment system and annual progress reports (APRs). The process for submitting Annual Safety Reports (ASRs) for Clinical Trials of Investigational Medicinal Products (CTIMP) to the …
The world of GPvP is highly regulated, but the 2024 GPvP symposium showcased how regulation, collaboration and innovation can work together to enhance compliance, provide opportunities for better ways of working, and improve patient lives. The Symposium welcomed over five …
Launch of a pilot Single Inspection Program, a global approach to GMP inspections of third country manufacturers. Health Canada, the Therapeutic Goods Administration (TGA) and the Medicines & Healthcare products Regulatory Agency (MHRA), all members of the Pharmaceutical Inspection Co-operation Scheme …
