We use some essential cookies to make this website work.
We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services.
We also use cookies set by other sites to help us deliver content from their services.
You have accepted additional cookies. You can change your cookie settings at any time.
You have rejected additional cookies. You can change your cookie settings at any time.
Departments, agencies and public bodies
News stories, speeches, letters and notices
Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
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.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
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)
How to join the phase I accreditation scheme.
Comply with good pharmacovigilance practice and prepare for an inspection.
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.
An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.
A poster explaining the different symbols used on medical devices.
Guidelines for communicating clear and relevant information about machine learning-enabled medical devices.
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.
The review of the safety of isotretinoin has concluded.
To assist sponsors and those conducting trials on implementing adequate oversight and monitoring processes for trials of investigational medical products.
Guidance for clinical trials that use Decentralised Manufactured Investigational Medicinal Products (IMPs).
Ten guiding principles that can inform the development of Good Machine Learning Practice (GMLP).
What 'single-use' means and what symbol is used by manufacturers to show this.
Don’t include personal or financial information like your National Insurance number or credit card details.
To help us improve GOV.UK, we’d like to know more about your visit today. Please fill in this survey (opens in a new tab and requires JavaScript).