Drug safety

Drug safety is an ethical and regulatory responsibility of Sopharma AD.

We conduct comprehensive safety monitoring throughout all stages of the lifecycles of products and evaluate their risks and benefits continuously to make sure they are safe and effective as they reach physicians and patients.


Our pharmacovigilance team, committed to keep society informed of the benefits and risks of our drugs, works in tandem with regulatory authorities to:

  • Monitor the safety of products during clinical trials and after their launch to the market.
  • Maintain a database of all reported adverse drug effects, which is used for collection and assessment of adverse events as well as for detection of new risks related to the medicines.
  • Actively inform the regulatory authorities of adverse effects reported by patients and healthcare professionals.
  • Prepare pharmacovigilance documents in accordance with legislation.

The pharmacovigilance system of Sopharma AD works under steady monitoring by regulatory authorities.