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Bureaucratic delays in drug authorization/ KLSH: Serious risk for cancer patients

2026-02-14 10:14:00, Denoncim CNA

Bureaucratic delays in drug authorization/ KLSH: Serious risk for cancer

CNA has published parts of the final report of the Supreme State Audit Office for days, which sheds light "on the availability of drugs for the treatment of tumor diseases."

After several days of continuous publications of data from the ALSHI report, today we are publishing a new disturbing fact that highlights a serious problem in the antitumor drug authorization system in our country.

According to the audit conducted by the Supreme State Audit Office, from the review of 25 cases of approval of marketing authorization for antitumor drugs, significant delays were found in the authorization process.

The HSE warns that bureaucratic delays are not simply an administrative problem, but a direct threat to the lives of patients awaiting antitumor treatment.

The SAI report clearly highlights that the current procedure is inefficient and lengthy, indicating the urgent need for legal and operational reform.

"From the moment of the proposal of the National Agency for Medicines and Medical Devices (NAMMD) until the issuance of the Order by the Minister of the Ministry of Health and Social Protection and the delivery of the authorization to the applicant, the average waiting time has resulted in 24 days. This delay hinders rapid institutional response in situations where urgent decision-making is required, especially for antitumor drugs," the report highlights.

The SAI adds that the current process creates a regulatory vacuum and limits the operational flexibility of the AKBPM, directly impacting the timely supply of medicines and increasing the risk for patients in urgent need of treatment.

"Since the technical, professional and scientific verification of the effectiveness and safety of medicines is carried out entirely by the Agency, it is reasonable that this competence should not remain merely recommendatory, but should end with the direct issuance of authorization by the Agency itself," the report states.

The SAI recommends that the Director General of the AKBPM, in cooperation with the Ministry of Health and Social Protection, take immediate measures to improve procedures and initiate relevant legal changes, with the aim of increasing effectiveness and guaranteeing the implementation of legality in the process of authorizing the marketing of medicines.

This new fact comes after several days of previous publications from the audit report, which reveals serious facts about the mismanagement of drugs and the way cancer patients are treated./ CNA





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