Medicinal Products

GCP Regulation

According to the current Law on Medicines, among the tasks of the Agency for Medicines and Medical Devices of Serbia (hereinafter referred to as the Agency), Article 3, point 4 states that the Agency is competent to conduct supervision of clinical trials.

In order to ensure compliance with the GCP guideline and local regulations, the Agency:

  • Conducts supervision in trial site where the sponsor conducts a previously approved clinical trial
  • Requires sponsors to report serious breaches (Serious Breach, SB) and significant protocol deviations (Protocol Deviation, PD)
  • May conduct supervision in trial sites where SB has occurred

Local regulation and international guidelines:

  1. Law on Medicines and Medical Devices (“Official Gazette RS”, No. 30/2010 i 107/2012, 105/17 another law, 113/2017 – another law)
  2. Regulation on Clinical Trials of Drugs in Human Medicine (“Official Gazette RS”, No. 51/2022, 65/2023, 86/2023, 97/2024) – available only in Serbian
  3. Guideline for Good Clinical Practice (“Official Gazette RS”, No.108/2017) revision 2
  4. Declaration of Helsinki – Ethical Principles for Medical research Involving Human Participants, adopted by WMA General Assembly, Helsinki, Finland, October 2024
  5. Guidance on Good Manufacturing Practice (“Official Gazette RS”, No. 97/2017)
  6. Regulations on Reporting, Collecting and Monitoring Adverse Drug Reactions (“Official Gazette”, No.107/2023) – available only in Serbian
  7. ICH E6 (R3) Guideline for good clinical practice (GCP) Step 5