MEDICINES AUTHORITY

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, and/or to identify any adverse reactions to one or more   investigational   medicinal   products and/or   to study   absorption, distribution, metabolism and excretion of one or more investigational medicinal products with the object of ascertaining their safety and/or efficacy.  

The legal framework for the local regulations on clinical trials is set out in the European Clinical Trials Directive 2001/20/EC.  The scope of this directive is to harmonise clinical trial requirements in the Member States of the European Union. It provides a framework for protecting people based on the Declaration of Helsinki and it also includes a regulatory means of Good Clinical Practice and Good Manufacturing Practice. It contains reference to issues such as the informed consent procedure, sets out special provisions for minors and disabled adults and also sets administrative provisions for clinical trials.

To conduct a clinical trial locally, one must submit applications with both the Medicines Authority and Ethics Committee and an authorization by the Medicines Authority and a positive opinion by the Ethics Committee are required. Further to this, the applicant and other concerned parties should abide by the local regulations and other requirements as deemed necessary by the Licensing Authority, including manufacture/import authorisation of the investigational medicinal products.

Requirements for the submission of an application to the Medicines Authority to conduct a clinical trial can be found here: The Guidance notes on Good Clinical Practice.

Relevant Links

 Guidance notes on Good Clinical Practice – Clinical Trials applications and notifications to the Medicines Authority, Malta

Clinical Trials Regulations, 2004 (LN 490)

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use

Good Manufacturing Practice in Respect of Medicinal and Investigational Medicinal Products for Human Use Regulations, 2004 (LN 485)

Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use

 Good Clinical Practice and Requirements for Manufacturing or Import Authorisation of Investigational Medicinal Products (Human Use) Regulations, 2006 (LN 119).

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 authorisation of the manufacturing or importation of such products

Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial

ICH Guidance for Good Clinical Practice

Declaration of Helsinki

Requirements to conduct clinical trials in Malta