As we reported, In August this year, the Government of Serbia adopted amendments to the Rulebook on clinical trials of human medicines (“Rulebook on Clinical Trials“), introducing significant changes to the clinical trials regime.
The first amendment limited clinical trials to public healthcare institutions, excluding privately-owned healthcare institutions from the clinical trials system. The second amendment completely excluded the possibility of conducting phase I clinical trials (phase I, Ia, and Ib) in Serbia.
The amendments caused backlash from the industry associations, which questioned the legality and meaningfulness of the changes.
Last week, on 11 October 2023, the Government of Serbia retracted the amendment adopted in August. The newest amendments of the Rulebook on Clinical Trials reintroduce the possibility of conducting phase I (I, Ia, and Ib) clinical trials in Serbia, however, only in public healthcare institutions. Such restriction does not apply to phases II, IIa, IIb, III, IIIa, IIIb, IV of clinical trials, which can be carried out in privately owned healthcare institutions.
The Government introduced a new requirement with respect to chief investigators, who now have to be employed full-time in a healthcare institution, with the exception of healthcare professionals who are employed as professors in institutions of higher education and have an agreement on the provision of medical services pursuant to the 2019 Healthcare Act. By this requirement, the Government addresses a concern it had regarding the quality of healthcare professionals engaged as chief investigators.
The newest amendments to the Rulebook on Clinical Trials will enter into force on 19 October 2023.