Good Clinical Practice: Background

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Introduction

The MHRA's Good Clinical Practice (GCP) Inspectorate is part of the Inspections & Standards Division of the MHRA. It assesses the compliance of organisations conducting clinical trials using investigational medicinal products with UK and EU legislation.

It is one of the five medicines inspectorates at the MHRA. The other four being:

In this section you will find information regarding the working of the GCP Inspectorate, its responsibilities and powers as well as details of its work. We have presented the information in an easy to follow question and answer format but if you require any further information please do not hesitate to contact us.


What is Good Clinical Practice (GCP)?

Definition from EU Directive 2001/20/EC, article 1, clause 2:

“Good clinical practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.”

Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible and accurate.

The principles of good clinical practice are outlined in articles 2 to 5 in the EU Directive 2005/28/EC.

ICH Topic E 6, the ICH Note for Guidance on Good Clinical Practice is an international standard for GCP. It was adopted by the CPMP (CPMP/ICH/135/95) in July 1996 and became operational in the European Union (EU) in January 1997. The ICH Note for Guidance on GCP replaced the previous European Community GCP Guidelines, which were implemented in 1991.


What is the MHRA GCP Inspectorate?

In the UK, the GCP inspectorate is responsible for inspecting clinical trials for compliance with Good Clinical Practice. Statutory Instrument 2004/1031 and subsequent amendment provides the legal basis for these inspections (see links below).

Inspections relating to the manufacture of Investigational Medicinal Products (medicines being tested) are carried out by GMP inspectors.

This statutory instrument implements, in the UK, the EU Directive 2001/20/EC, "on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for human use” and the EU Directive 2005/28/EC, “laying down the principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.”

The GCP inspectorate consists of a team of GCP inspectors. By conducting inspections at the sites of organisations conducting or involved in clinical trials, the GCP Inspectors assess compliance with the requirements of legislation and guidelines relating to conduct of clinical trials involving investigational medicinal product. Each Inspector has a statutory duty to assess compliance with medicines legislation and holds a warrant accordingly.


What does the MHRA GCP Inspectorate do?

The function of the GCP Inspectorate is to assess the compliance of organisations with UK and EU legislation relating to the conduct of clinical trials in investigational medicinal products. This is achieved through carrying out inspections of sponsor organisations that hold clinical trial authorisations (CTA), organisations that provide services to clinical trial sponsors or investigator sites. These include pharmaceutical companies, contract research organisations, non-commercial organisations such as universities, NHS Trusts and charities, investigational trial sites, clinical laboratories, GCP archives and other facilities involved in clinical trial research. GCP inspections may also take place following a referral, for example, information received by the inspectorate relating to GCP non-compliance.

MHRA GCP inspectors attend the ad hoc meetings of EU GCP Inspectors, which are held on a quarterly basis at the EMEA. The aim of these meetings is to assist with harmonisation and the development of procedures, for EU GCP inspections. The inspectorate also provides UK representation at the Commission for the development of GCP legislation and guidance.

The MHRA GCP Inspectorate has participated in joint GCP inspections with inspectors from a number of EU Member States. In addition, the GCP Inspectorate has been instrumental in providing advice and training to GCP inspectors from countries within and outside the EU. GCP Inspectors participate in clinical research seminars and training courses.

GCP Inspectors also shadow inspections conducted in the UK, by foreign agencies, for example, the American FDA, the Japanese Ministry of Health and Welfare.

The GCP inspectorate organises a GCP consultative committee with relevant interested parties and also answers any queries, for example relating to GCP issues, GCP inspections and also, parliamentary questions. The GCP Inspectorate holds symposia every year, in which updates from the inspection programme and new issues that may impact on the conduct of research e.g. new legal requirements, are reviewed. For upcoming events provided by the MHRA please visit the Conferences Section.


What rights do GCP inspectors have?

Inspectors have rights conferred under Part 16 of the Human Medicines Regulations 2012. These rights are cross-referred to in Part 8 and Schedule 9 of the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended (SI 2004 No. 1031). The Human Medicines Regulations 2012 make a number of relevant amendments to the Medicines for Human Use (Clinical Trials) Regulations 2004, these amendments have been necessary following the completion of the MHRA's project to consolidate UK medicines legislation.

Inspectors have the right to enter any premises involved in clinical trials of investigational medicinal products to carry out inspections, take samples, require the production of books and documents, and to take copies of, or copies of entries in, such books and document and seize and detain substances, articles and documents. It is a criminal offence under Regulation 334(3) of the Human Medicines Regulations 2012 to intentionally obstruct an Inspector during the conduct of an inspection.


How is the MHRA GCP Inspectorate organised?

An organogram for the GCP Inspectorate can be viewed here.


Who does the GCP Inspectorate report to?

The Inspectorate reports to Gerald Heddell, Director of the Inspection, Enforcement & Standards (I, E&S) Division. Mr Heddell is a member of the MHRA’s Executive Board which reports to Department of Health ministers via the MHRA's Agency Board.


Where is the GCP Inspectorate located?

The GCP Inspectorate operates from three locations:

  1. GCP Inspectorate, 151 Buckingham Palace Rd, London SW1W 9SZ
    Telephone: 0203 080 6000
  2. GCP Inspectorate, MHRA, 2 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW
    Telephone: 01707 299130
  3. GCP Inspectorate, MHRA, 2a Hunter House, 57 Goodramgate, York, YO1 7FX
    Telephone: 01904 610556

These offices are staffed from 9.00 to 17.00. Outside these hours a voice mail system is in operation.

Contact for further information
Further information on this part of our website or to request advice relating to a GCP matter, please contact either:

  1. info@mhra.gsi.gov.uk
  2. clintrialhelpline@mhra.gsi.gov.uk

External links

(The MHRA is not responsible for the content of external internet sites.)


Page last modified: 21 January 2013