Good Clinical Practice



Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.  Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

Clinical trials are undertaken to obtain information on how a medicinal product works, what side-effects may occur when taking this product and the way it is metabolised by the body. This will help to build up a history on the product in question such that data on the safety and efficacy can be collected, subsequently enabling a decision to be taken on the benefit or otherwise of the product to the patients.

The Declaration of Helsinki is a statement of ethical principles developed by the World Medical Association to provide guidance to physicians and other participants in medical research involving human subjects. The Declaration includes principles on safeguarding research subjects, informed consent, minimising risk and adhering to an approved research plan/protocol.

Good Clinical Practice Inspections

GCP Inspections are carried out by the Inspectorate and Enforcement Directorate of the Medicines Authority in order to assess the compliance of the clinical trial with the International Conference on Harmonisation (ICH) guideline for Good Clinical Practice (ICH Topic E6(R1)), Directive 2001/20/EC (as amended), Medicines Act (Cap. 458) and its subsidiary legislation LN 490 of 2004 and LN 119 of 2006.

Clinical trials carried out in Malta are selected on a risk assessment trigger basis taking into account documented triggers such as the phase of the study, whether the study is double blind or not, presence of children in the trial, the number of patients participating in the trial, trials with great relevance to public health, whether products to be used in the trial are special products such as vaccines or products with a narrow therapeutic range, any complaints received pertaining to the study in question, the competence of the principal investigator i.e. whether study being carried out concerns his/her field of competence and whether the study is ongoing or not. Trials scoring the highest points based on the above criteria would thus be chosen to be inspected.

GCP Inspections may be carried out at sponsor sites, investigator sites, CRO sites, clinical laboratory sites as well as at a non-commercial organization such as a university.

Guideline on Good Clinical Practice

Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - ICH Topic E6 (R1)

Legislation on Clinical Trials

EU Legislation

Directive 2001/20/EC (as amended) - 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

Directive 2005/28/EC - laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorization of the manufacturing and importation of such products

Maltese Legislation

S.L. 458.43 - Clinical Trial Regulations (as amended).

S.L. 458.47  - Good Clinical Practice and Requirements for Manufacturing or Import Authorisation of Investigational Medicinal Products (Human Use) Regulations.

Further information

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