Medicines and Healthcare products Regulatory Agency (MHRA)
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department for Health and is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe.
A key objective of the MHRA is to encourage and facilitate development of products that will benefit public health. The MHRA aims to do this by communicating regulatory requirements in ways which are accessible to a variety of organisations and individuals.
Much of the day-to-day information and guidance on legislation produced by the MHRA is available directly on their website www.mhra.gov.uk. However, various must-have reference titles and guides relating to specific areas of the MHRA's work are published by and available to purchase from TSO:
The Good Clinical Practice Guide is a brand new
publication covering legislation, guidance and good practice that relates to
the conduct of clinical trials of medicinal products for human use in the UK.
Click here to find out
more and to order
UK Pharmacopoeial activity is carried out within the Inspection, Enforcement and Standards Division of MHRA by the British Pharmacopoeia Commission Secretariat and the British Pharmacopoeia Laboratory. They are responsible for producing:
The British Pharmacopoeia - the
official, authoritative collection of standards for UK medicinal substances for
human and veterinary use.
Click here to find out more and to
order
British Approved Names (BAN) - the
official dictionary of names for UK medicinal substances.
Click
here to find out more and to order
Coming Soon
Rules and Guidance for Pharmaceutical Manufacturers
and Distributors 2013 (Orange Guide)
Familiarly known as
the 'Orange Guide', Rules and Guidance for Pharmaceutical Manufacturers and
Distributors 2013 is an essential publication for anyone subject to an MHRA
inspection.
Click here to find out more and
to order
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