Antitumor drugs without laboratory control/ KLSH: Lack of tests at AKBPM, risk to patient safety

2026-02-06 14:51:00, Denoncim CNA

Antitumor drugs without laboratory control/ KLSH: Lack of tests at AKBPM, risk

An audit conducted by the Supreme State Audit Office has highlighted a worrying situation at the Control Laboratory at the National Agency for Medicines and Medical Devices, where during the years 2021, 2023 and 2024 no laboratory analysis was performed on drugs for the treatment of tumor diseases, except for 8 analyses recorded during 2023. While during the period January-March 2025, only one laboratory analysis was performed.

"From the audit of the data made available, it results that during the years 2021, 2023 and 2024, the Control Laboratory at the National Agency for Medicines and Medical Devices (AKBPM) did not perform any laboratory analysis on samples of drugs for the treatment of tumor diseases, submitted within the framework of marketing authorizations. During 2023 alone, 8 such analyses were carried out, of which 4 for drugs intended for hospital use, while in the period January-March 2025, only one analysis was recorded. These data indicate a minimal and unsustainable level of laboratory control on antitumor drugs, raising serious concerns about the quality and safety of these pharmaceutical products circulating on the market," the SAI report underlines.

The audit highlights that the Control Laboratory did not analyze the samples accompanying the documentation for granting marketing authorization, in accordance with the pharmaceutical requirements or analytical methods specified by the manufacturer, making this action contrary to the Agency's Internal Regulation.

According to the report:

"For the period 2021–2024, the laboratory sector has no official deadlines for conducting the analyses, and the work process is not documented in a structured manner, from sample receipt to the extraction and reporting of the result."

There is also a lack of a methodology for selecting samples from the list of imported medicines, and there is no clear division of responsibilities between technical staff or standard working procedures that should be followed.

The situation becomes even more critical considering the widespread circulation of medicines imported from various countries in the Balkans and the world, which are provided with import authorization without being accompanied by mandatory laboratory control over their composition and quality.

The SAI report states that:

"The lack of laboratory analysis and standardization of the control process directly affects the functional mission of the Control Laboratory at the AKBPM, creating serious gaps in guaranteeing a safe, quality pharmaceutical market that responds to public health needs."

Based on the audit findings, the SAI recommends that:

"AKBPM should ensure the performance of laboratory analyses for drugs submitted for marketing authorization, with a particular focus on antitumor drugs, by implementing standard operating procedures and clear methodologies for sample selection and control."

The Medicines and Medical Devices Distribution Sector should review and strengthen regulatory mechanisms, so that every drug authorized for marketing is accompanied by laboratory controls and safe and fair access of patients to vital medicines is guaranteed.”

Antitumor drugs without laboratory control/ KLSH: Lack of tests at AKBPM, risk

The KLSH report highlights another serious problem that directly affects the lives of patients using antitumor drugs, jeopardizing the quality and safety of medical treatment in the country./ CNA