Medicinal Clinical Trials

Overview

Clinical trials are performed to find out how a medicine works, what side effects it causes and how it is metabolised by the body. Trials are conducted on new medicines and at times using medicines that are already on the market in Malta. Clinical trials refer to any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more Investigational Medicinal Products (IMP). They are also used to identify any adverse reactions to one or more IMPs, and/or to study absorption, distribution, metabolism and excretion of one or more IMPs with the object of ascertaining their safety and/or efficacy. The legal framework for clinical trials with medicinal products for human use is set out in the Clinical Trials Regulations (Subsidiary legislation 458.43) implementing the European Clinical Trials Directive 2001/20/EC.

What you'll get

An authorisation of a clinical trial granted by the Medicines Authority valid for a particular clinical trial conducted in Malta.

Eligibility

The person, individual or group that takes overall responsibility for the trial (the sponsor), but a doctor or a dentist (the investigator) must always participate in the conduct of the trial.

How to apply

Fill in the online form through the Common European Submission Portal or by sending application on electronic media (CD/DVD) to the:
Medicines Authority
Licensing Directorate
The Malta Life Sciences Park
Sir Temi Zammit Buildings
San Ġwann SGN 3000
apply