In order to be treated with a new medicine, the citizens of Serbia have been waiting for the approval of the competent institutions for several years, as long as it takes for that medicine to go through long and demanding procedures of the competent institutions. These are a series of related procedures such as approving clinical trials, obtaining a marketing authorization for the medication, determining the maximum price of the medication, placing it on the list of medications financed from compulsory social insurance, as well as approving each individual promotional material.
-We are pleased that the Medical Devices Agency of Serbia (ALIMS) has initiated the digitalization of these procedures, for now only in part of clinical trials, and we expect that in a few months the submission of requests and documentation for clinical trials will begin exclusively through the new portal ePortalLek (eMedicationPortal) - said Una Ljubičić, President of the Healthcare Alliance at NALED and Regional Market Access and Pricing Manager of Pfizer.
ALIMS and the Ethics Board of Serbia (EOS) will benefit from the new electronic system, because the system will be automated and no time will be spent on unnecessary communication by emails or letters between the two key institutions responsible for resolving requests. Benefits will also be seen by pharmaceutical companies that will submit completely electronic requests, without any paperwork, but will also be able to check the processing status of their case at any time. A more efficient procedure leads to a faster resolution of cases, all with the goal that the citizens of the Republic of Serbia receive adequate and safe therapy as soon as possible.
- In order to fully support investments in research and development of medicines in Serbia, in addition to digitalization of the procedure, our analyzes show that it is necessary to introduce a deadline for checking the formal completeness of requests, bearing in mind that frequent subsequent amendments are one of the reasons for lengthy procedures. but also to appoint the secretary of the Ethics Board of Serbia, as a person who would be responsible for organizing all the activities necessary to resolve the request within the legal deadlines - Ljubičić believes.
However, even after the digitalization of clinical trials, there will still be a long way to go for new drugs to reach the Serbian market.
Although the legal deadlines for issuing a medication license are 210 days, or 150 under the accelerated procedure, in practice they can take longer, more precisely several years, which is why Serbian citizens get access to medications much later than patients in the European Union. The reason for this is recognized by NALED in a complicated procedure that includes the submission of requests in both paper and electronic form, but also "pedestrian" processing by the competent institutions. Currently in Serbia, it takes 9 to 18 months to obtain a medication license, while examples from the region show that all work can be completed in just a few months.
NALED and the Balkan Center for Regulatory Reform, within the project Optimization of administrative procedures, with the support of the Public Policy Secretariat of the Republic of Serbia, gave recommendations for improving the procedures for issuing licenses for medicines. In addition to digitalization, they include the abolition of the requirement to submit a sample of the medication and the submission of a certificate of a pharmaceutical product, because it is a document without essential value, which is intended primarily for countries without adequate quality assessment institutions.
The analysis also showed that all the procedures that a medication has to go through in order to be on the Serbian market are common and often take too long due to the incoherence of databases in the Ministry of Health, and recommendations are given on how institutions within the health system should connect and exchange data.
20.03.2019Serbia is significantly lagging behind the countries in the region and Europe...Read more