| Description: |
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. |
