Are you taking safe medicines? Here’s what the State Audit Office report reveals

Drugs for the treatment of cancer in Albania have entered the market without undergoing mandatory laboratory tests for their quality and composition. This is one of the most serious findings of the latest report by the Supreme State Audit (KLSH), which raises alarms about pharmaceutical safety in the country.

According to the report, during the period 2021–2024, the Control Laboratory at the National Agency of Medicines and Medical Devices did not carry out any comprehensive analyses of antitumor drugs. In fact, in 2023, only eight analyses were conducted in total, of which only four concerned drugs used in hospitals. In the first three months of 2025, only one analysis was performed.

This constitutes a serious violation of the law and the obligations of the Agency to guarantee the safety and effectiveness of medicines circulating on the market. Patients facing serious illnesses, such as cancer, are left without any assurance regarding the quality of the drugs they take daily.

In addition to the lack of analyses, the Supreme State Audit (KLSH) also uncovered the complete absence of a clear methodology for sample selection, deadlines for testing, and the allocation of responsibilities among staff. The technical control process—from sample collection to the publication of results—has been carried out without documented protocols and without any officially approved standards.

These gaps indicate a deep institutional failure and increase the risk to patient safety, especially for sensitive treatments such as those for cancer. The situation underscores the urgent need for reform in the pharmaceutical control mechanisms in the country.

“KORÇA BOOM”