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 In Malta, clinical trials must be notified to the Maltese Licensing Authority (through the Medicines Authority) by 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. The Medicines Authority evaluates both the quality of the investigation and the patient safety of clinical trials. Clinical trials must also be notified to the health ethics committee established under the Clinical Trials Regulations (Subsidiary legislation 458.43), which performs an overall assessment of the trial's ethical aspects. Before a clinical trial can be started, approvals must be obtained from both the health ethics committee and the Licensing Authority.
The requirements necessary to conduct a clinical trial as well as notification of amendments to an already authorised clinical trial can be found in The Guidance notes on Good Clinical Practice -1/10/2010 . The guideline provides information on how to apply for a trial, assessment timelines, fees, how to report adverse events and inspections on clinical trials.
The Clinical trial Application Form can be accessed here
In April 2009 the Clinical Trials Facilitation Group (CTFG) launched the Voluntary Harmonisation Procedure (VHP). This procedure allows sponsors of EU multi-national clinical trials to obtain a harmonised assessment of their Clinical Trial Authorisation (CTA) application by all the National Competent Authorities (NCAs) involved. The sponsor receives a single, harmonised set of questions which have been consolidated following scientific discussion between the Lead Member State (LMS) and the other Member States concerned. A single set of core documents are provided electronically to the VHP coordinator and a simultaneous and coordinated assessment of the data is undertaken according to fixed timelines by the Member States concerned.
Further information on how to submit an application via VHP and the documentation required can be found in the Guidance document for a Voluntary Harmonisation Procedure (VHP) for the assessment of multinational Clinical Trial Applications
For access to information on the authorised pharmaceutical clinical trials that are ongoing in Malta an EU Clinical Trial public register is available.
The legal obligations of the sponsors of clinical trials are specified in Directive 2001/20/EC and the Clinical Trials Regulations (Subsidiary legislation 458.43). Further guidance on the requirements of sponsors and investigators is outlined in the "Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use" issued by the European Commission
Additional guidance on Serious Unexpected Suspected Adverse Reactions (SUSARs) and how to report SUSARs to the Medicines Authority is available in The Medicines Authority's Guidance Notes for Pharmaceutical Companies on Pharmacovigilance Obligations & Adverse Drug Reaction (ADR) Reporting Requirements for Medicinal Products for Human.
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