Life Sciences Bulletin: Phase I clinical trials open to Serbian private healthcare

On 3 December, the Serbian Ministry of Health adopted the Amendments to the Rulebook on Clinical Trials of Human Medicine, further facilitating the conduct of clinical trials in Serbia by streamlining procedures and lifting certain administrative burdens. The amendments took into account many of the comments and proposals submitted by the professional public, NGOs and other stakeholders.

Key amendments:

• Phases I, Ia and Ib of clinical trials no longer have to be performed in a public healthcare institution in order to be acceptable to the Serbian regulator.
• The requirement for the principal investigator to provide evidence of participation in previous clinical trials is now abolished.
• When considering the documentation for the clinical trial, ALIMS, the Serbian regulator, is now able to take into consideration decisions and reports from regulators of EU members states (i.e., the EMA) or regulators from states that are founding or permanent members of the ICH.
• Information on all approved clinical trials will now need to be published on the ALIMS website.
• ALIMS will simultaneously issue any import approvals for a medicinal product undergoing a clinical trial and the approval of the clinical trial for that product, provided that a complete request for import approval was duly submitted by a licensed wholesaler. This is expected to considerably streamline the import process.

The above amendments will come into effect on 14 December.