Erjon Spahiu, when he took office in November 2025 as head of the National Agency for Medicines and Medical Devices, stated that his focus was on cooperation with the European Medicines Agency, as a fundamental condition for advancing healthcare standards.
But from theory to practice, it seems to be failing from the start of the direction, as it is not implementing the EMA's decisions. The European alarm effect describes the antitumor drug Nilotinib Pharmascience as unsafe, where in many developed EU countries registration has been refused due to inaccurate clinical data, while in Albania the doors are opened through the company Megapharma.
The questionable process at the National Agency for Medicines and Medical Devices also highlights the unequal treatment of applicants for the registration of medicines. When the Albanian distributor owned by Rasim Hamzaraj and the influence of Klodian Allajbeu was turned a blind eye during the initial analyses that did not even meet the local laboratory criteria, the application for the drug Nilotinib from the company Zentiva was immediately rejected for the same laboratory problem, without giving it any opportunity to correct it. This double standard raises serious doubts about the violation of the principle of equality before the law and selective favoritism of private interests.
Top Channel sent a request for information to the AKBPM, as to why two positions were taken on the same medicine submitted by different operators, but there was no explanation, only a statement that the applications are reviewed in accordance with the law on medicines and pharmaceutical services. Since the evidence in this case shows the opposite, this action of the National Medicines Agency is in serious violation of the law and contrary to the standards of the European Medicines Agency.
Serious suspicions have been raised by sources at Top Channel that the Medicines Agency, among other things, has modified the methodology of laboratory analysis to favor the company Megapharma during the registration process of the antitumor drug Nilotinib Pharmascience. It is learned that even after replacing the initial samples that resulted problematic in the dissolution test, one of the most critical parameters for the safety and effectiveness of the drug, the criteria were still not met, which has led to the intervention of the analysis method itself.
So, not only did the AKBPM not definitively reject Megapharma's request, but although the first application for Nilotinib was discontinued in June 2025 due to unacceptable results, the Medicines Agency subsequently allowed the replacement of samples and the reopening of the application. Despite the official statements of the AKBPM that Nilotinib is not yet authorized for marketing in Albania, sources from the Ministry of Health confirm that the authorization was granted on December 30, 2025, further deepening the uncertainties and lack of institutional transparency in this matter. /Top Channal/
