Introduction
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), Commission Implementing Regulation (EU) 2017/556, EU Regulation 536/2014, Directive 2005/28/EC, Medicines Act (Chap. 458) and its subsidiary legislation SL 458.43 (Clinical Trials Regulations) and SL 458.47 (Good Clinical Practice and Requirements for Manufacturing or Import Authorisation of Investigational Medicinal Products (Human Use) Regulations). ).
Clinical trials carried out in Malta are selected for inspections priority 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 in the field of trial study, and whether the study is ongoing or not. Trials scoring the highest points based on the above criteria would thus be chosen on priority 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 organizations such as a university.
GCP inspections can take place both domestically as well as outside of the EU as required. These GCP inspections will be conducted by the Malta Medicines Authority Medicines Inspectors who can be accompanied, if additional expertise is required, by internal experts such as clinical trial assessors as well as by external experts, including GCP inspectors from other Union competent authorities. Powers for experts to accompany and take part in GCP inspections are mandated by the Medicines Act (Chapter 458), articles 101(1) and Article 104 [1] and by SL458.47 (article 21).
Guideline on Good Clinical Practice
Note for Guidance on Good Clinical Practice - ICH Topic E6
Legislation on Clinical Trials
EU Legislation
COMMISSION IMPLEMENTING REGULATION (EU) 2017/556 on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council
EU REGULATION No. 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
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.
CT Inspections Procedures.
Criteria for a GCP inspection (IN 021)
Preparing for a GCP inspection (IN 022)
Conduct of a GCP inspection (IN 023)
Preparation of a GCP Inspection Report (IN 024)
Further information
For further information you can send an email on inspectorate.adm@gov.mt