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Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Guidelines for communicating clear and relevant information about machine learning-enabled medical devices.
Background In 2021, the U.S. Food and Drug Administration (FDA), Health…
Keep up to date with the latest information from the UK GLP monitoring authority.
Pharmacovigilance system requirements
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
How to join the phase I accreditation scheme.
Guidelines to help mitigate and manage medicine shortages.
Comply with good pharmacovigilance practice and prepare for an inspection.
The MHRA have implemented a dual strategy for a risk-adapted approach to clinical trials in the UK.
An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.
Industry must notify the MHRA if they will not be using these flexibilities
Some of the different symbols used on medical devices.
This guide has been provided to reduce the burden when preparing responses to Post Inspection Letters.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
How to best protect patients and volunteers during magnetic resonance imaging (MRI) examinations.
Guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home
To assist sponsors and those conducting trials on implementing adequate oversight and monitoring processes for trials of investigational medical products.
The UK Good Laboratory Practice Monitoring Authority (UK GLPMA) recognises that there are potential challenges COVID-19 will present to members of the GLP monitoring programme.
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