MALTA Law and Practice Contributed by: Deo Falzon, Fenech & Fenech Advocates
2. Clinical Trials 2.1 Regulation of Clinical Trials
Clinical investigations involving CE-marked devices used outside the scope of their intended purpose (per MDR Article 74) or in multi-country studies (Article 78) must also follow the specific regulatory pathways out- lined in the MDR. The same processes apply to in vitro diagnostic medi- cal devices under the IVDR. 2.3 Public Availability of the Conduct of a Clinical Trial Under Regulation (EU) 536/2014, clinical trials author- ised in Malta are recorded in the EU Clinical Trials Information System (CTIS), which is publicly acces- sible. The Regulation mandates that summaries of trial results and layperson summaries are uploaded irrespective of trial outcome, enhancing transparency. Similarly, the MDR obliges sponsors to report results of clinical investigations in EUDAMED, including summa- ries understandable to the public (Articles 77 and 80). Until EUDAMED is fully functional, summary reports are submitted directly to the competent authority. Data is processed and redacted to comply with the General Data Protection Regulation (GDPR) and other applicable legislation safeguarding patient details. 2.4 Use of Online Tools to Support Clinical Trials There is no express prohibition under Maltese Law on using digital or online tools to support clinical tri- als (eg, for recruitment, eConsent, monitoring, or data collection). However, their use must comply with the General Data Protection Regulation (GDPR) (Regula- tion (EU) 2016/679) and Good Clinical Practice (GCP) guidelines, including ICH E6 (R2). It must also be approved by the relevant Research Ethics Commit- tee, especially if involving patient interaction. Online tools must not compromise data integrity, par-
Clinical trials for medicinal products in Malta are regulated under the Clinical Trials Regulation (EU) No 536/2014, which became fully applicable on 31 Janu- ary 2022. This Regulation repeals Directive 2001/20/ EC and establishes a harmonised EU-wide framework for authorising, conducting, and supervising clinical trials through the Clinical Trials Information System (CTIS). The Malta Medicines Authority (MMA) is the nation- al competent authority responsible for oversight. In addition, the Malta Council for Science and Technol- ogy (MCST) and Research Ethics Committees (RECs) established under the national bioethics framework contribute to the ethical review of clinical trials. Clinical investigations for medical devices are gov- erned by Regulation (EU) 2017/745 (MDR), Articles 62–82, and Annex XV. For performance studies for in vitro diagnostic devices, Regulation (EU) 2017/746 (IVDR), Articles 57–77, and Annex XIV are used. National implementation support is provided through regulatory guidelines published by the MMA. An ethics committee is also used in the process. 2.2 Securing Authorisation to Undertake a Clinical Trial A clinical trial sponsor must submit an application for medicinal products through the CTIS portal. The MMA, acting as the Reporting Member State (RMS) or Concerned Member State (CMS), conducts the sci- entific and regulatory assessment in accordance with Regulation (EU) 536/2014. Ethical approval is required from a Research Ethics Committee, which must issue its opinion within the timeframe established in the Regulation. The MDR requires submission to the MMA through national channels for any clinical investigations on medical devices, pending full EUDAMED functional- ity. Investigations involving medium to high-risk or implantable devices generally require prior authorisa- tion, whereas other classes may proceed upon notifi- cation, provided ethical clearance is obtained.
ticipant privacy, or ethical standards. 2.5 Use of Data From Clinical Trials
Data derived from clinical trials is generally considered a special category of personal data under Article 9 of the General Data Protection Regulation. The use, storage, and transfer of such data must be justified
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