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Accelerating Clinical Trials in the EU

Initiatives in Malta

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Support mechanisms for non-commercial clinical trials Level
NationalEU Level (Multinational)Global
Dedicated webpage    
Training courses    
Scientific advice     
Helpdesk, regulatory, CTIS and ethics support    
Other services by National Competent Authority

Fee reduction / waiver

Fees for academic research without support from industry benefit from a fee exemption of 70% of full fee. Decisions on fee exemptions are at the discretion of the Medicines Authority.

For more information: LEĠIŻLAZZJONI MALTA (legislation.mt)

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Services by ethics committee    
Public GCP support    
Public research office    
National funding and other financial support

National funding support to support companies planning to set up in Malta and run clinical trials may be possible through Malta Enterprise.

For more information: Incentive Guidelines (maltaenterprise.com). 

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Funding coordination and navigation of research infrastructure    
Support identifying research networks    
Other support mechanisms

Help with reporting of Suspected Unexpected Serious Adverse Reaction (SUSAR)

Upon request, the Malta Medicines Authority assists non-commercial sponsors with electronic report submission to the EudraVigilance clinical trial module (EVCTM). Requests should be submitted to info [dot] medicinesauthorityatgov [dot] mt (info[dot]medicinesauthority[at]gov[dot]mt) at the time of submission of the clinical trial application to facilitate timely completion of arrangements.

For more information: Malta Medicines Authority: Guidance Notes for Pharmaceutical Companies on Pharmacovigilance Obligations for Medicinal Products for Human Use

The Malta Medicines Authority also respons to queries from non-commercial sponsors and may arrange meetings when asked to explain the requirements for clinical trials and regulatory pathways.

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