UKCRC Regulatory And Governance Advice Service

Latest News

GMP - Annex 13 Revision

The long awaited revision to Annex 13 (Investigational Medicinal Products) of the EU Guidelines to Good Manufacturing Practice of Medicinal Products for Human and Veterinary Use was adopted by the Commission on 31st January 2010, published on 3rd February 2010 and comes into operation on 31st July 2010. It can be downloaded from the European Commission website

Coordinated By

Medical Research Council

MRC Regulatory Support Centre works in partnership to promote good quality, ethical research that involves people as participants, their tissues or data.

NIHR Clinical Research Network Coordinating Centre

The NIHR Clinical Research Network Coordinating Centre manages the NIHR Clinical Research Network in England to support and deliver high quality clinical research studies.

Welcome to the UKCRC Regulatory and Governance (R&G) Advice Service

The UKCRC Regulatory and Governance (R&G) Advice Service is a UK-wide resource for those involved in health research (including non-portfolio studies). The Advice Service aims to provide consistent and authoritative advice on a range of regulatory and governance issues, primarily to support local advice providers, such as NHS R&D departments, university research managers, MRC employees or Clinical Trial Unit (CTU) staff without access to R&D offices within the NHS or universities. The Advice Service does this by providing:

A route for handling complex queries, such as those involving more than one regulatory issue
On-line resources such as Tool Kits and Question & Answers

Following an external evaluation of the Service, the role of the Service is changing, more information will be posted here when details have been finalised.

Who should use this service?

Local regulatory or governance (R&G) advisers such as NHS R&D Departments, university research managers, MRC employees and Clinical Trial Unit staff without access to R&D offices within the NHS or universities. If you are a researcher with a query, we would advise you, in the first instance, to contact your local university or NHS R&D office.

What kind of queries can you submit to us?

Queries regarding regulatory or governance issues about research with human participants, their organs, tissue, or data. You may wish to have a look at the Q&A page to see if your query has already been answered.

The delivery of the UKCRC R&G Advice Service is being coordinated by the NIHR Clinical Research Network Coordinating Centre NIHR CRN CC and MRC Regulatory Support Centre, and is supported by a network of regulatory agencies and governance bodies.

Visit About Us for more information on the background to the Service
View the Q&A page to see if your query has already been answered
Submit a query to the Advice Service using a simple on-line form