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Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
The review of the safety of isotretinoin has concluded.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
Keep up to date with the latest information from the UK GLP monitoring authority.
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.
Comply with good pharmacovigilance practice and prepare for an inspection.
How to join the phase I accreditation scheme.
An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.
Guidelines to help mitigate and manage medicine shortages.
The MHRA have implemented a dual strategy for a risk-adapted approach to clinical trials in the UK.
Guidelines for communicating clear and relevant information about machine learning-enabled medical devices.
A poster explaining the different symbols used on medical devices.
Information for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.
What 'single-use' means and what symbol is used by manufacturers to show this.
Checklists providing a practical guide to using medical devices in a range of healthcare settings.
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.
Ten guiding principles that can inform the development of Good Machine Learning Practice (GMLP).
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