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
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to use a cost effectiveness analysis to evaluate your digital health product.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to use a multiphase optimisation strategy (MOST) to evaluate your digital health product.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Steps SMEs can take when bidding for government contracts so they can compete with larger companies.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
Advice for manufacturers of Class I medical devices for placing products on the UK market
Helping public health practitioners conducting evaluations – using outcome evaluations to find out if an intervention works.
Advice on writing clear notices and maximising replies to your FSNs.
How to use an ethnographic study to evaluate your digital health product.
Information on good laboratory, manufacturing and distribution practice, good pharmacovigilance practice (GPvP), out-of-specification investigations, inspection metrics and fees.
The Department has issued guidance on the use of the prescribing Better Care Better Value Indicators, especially in relation to the indicator for statins.
Apply for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Guidance for industry on flexible approaches we are taking on good distribution practices.
Data on the real-world efficacy of the COVID-19 vaccines.
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).