S.L. 458.43 ст. 2Scope. Cap. 458.

(1) These regulations apply Directive 2001/20/EC and shall regulate the conduct of clinical trials, including multi-centre trials, in Malta on human subjects involving medicinal products as defined under the Medicines Act and in particular relating to the implementation of good clinical practice. These regulations shall not apply to non-interventional trials.

(2) All clinical trials including bioavailability and bioequivalence studies shall be designed, conducted and reported in accordance with the principles of good clinical practice. The various aspects associated with submissions including notifications and requests to the Licensing Authority and the Ethics Committee and any other procedures and requirements related to clinical trials as deemed necessary by the Licensing Authority, shall be in accordance with the publications related to clinical trials published and, or adopted periodically by the Commission as deemed necessary by the Licensing Authority.