In previous years, the Institute for Medicines and Medical Devices (CInMED) achieved fascinating results, which positioned it as an institution that guarantees the quality and safety of medicines and in which citizens and the health system can trust, said the director of the Institute, Snežana Mugoša.
In an interview with the MINA agency, she said that teamwork, collegiality, cooperation and positive energy were the right recipe to achieve great success and remarkably improve work processes in the period of one year.
"We managed to achieve the goal of positioning the Institute, both nationally and internationally, as an institution that guarantees the quality, safety and efficiency of medicines and medical devices, which is independent and impartial and whose work citizens and the entire health system can have a lot of trust", pointed out Assoc. dr sci spec Mugoša.
She said that every institution, including the Institute, is represented by its employees, and that managers experienced their role in the right way - to be motivators and creators of conditions that create a stimulating environment for achieving real results.
"Even though we still have years ahead of us in which we will achieve new successes, but also learn from each other and grow and develop together, I am convinced that the Institute has created a winning team," Mugoša pointed out.
She said that in the last year, a lot of work has been done at the Institute on improving the organization of work and valorizing the abilities, expertise, exceptional ideas and leadership skills of the experts, as well as on raising their competencies.
According to her, the new management of the Institute introduced organizational transformation, new business standards and modern human resource management models were applied, and colleagues were shown trust.
"This led to the fact that today we can confidently say that we have achieved fascinating results that we are really proud of, and which, I am convinced, will serve to honor future generations, all our collaborators, the health system and our country," she announced. Mugosha.
She said that it was not easy to preserve the Institute's independence in a turbulent period, which was characterized by the COVID-19 pandemic and very complex political, social and economic events.
"Reforms that we fought for with great commitment, with our internal and external experts and collaborators, without compromise and despite great pressures, were the basic responsibility of the management team of an institution that is extremely important in the health protection system of our citizens," stated Mugoša.
She said that the Institute significantly shortened the deadlines for issuing permits for putting innovative drugs on the market and thus created a precondition for the availability of new therapies on the List of Medicines.
According to Mugoša, efficiency has increased in the approval procedures of generic drugs, which, according to her, will enable large savings for the health system and increase the number of therapeutic options for health workers and patients by placing them on the List of Medicines.
"We approved the first veterinary drugs and thus laid the foundation for the regulation of the market of veterinary drugs." We have prepared numerous by-laws, we are nearing the end of the development of the new portal, and the digitalization of all business processes has begun with the introduction of applications that are mandatory in the European Union," added Mugoša.
As she indicated, the Laboratory of the Institute works intensively to ensure the protection of citizens from medicines that do not meet the strict quality standards that CInMED applies in its daily work, while the inspectorate carries out supervision, which prevents the entry of counterfeit medicines into the legal supply chain.
She said that CInMED is here to offer and seek a solution and that, thanks to this approach, it receives praise for its work from clients and partners from numerous relevant international addresses.
"I especially want to highlight the support that the Institute received from the highest representatives of the European Commission, the European Medicines Agency, as well as European and international regulatory authorities in the field of drugs and medical devices regarding the Institute's further development path and joining the European family of regulators, in some of our jurisdictions even before Montenegro's accession to the European Union", stated Mugoša.
When asked how it is assessed when the health benefit of a drug is greater than its side effects, Mugoša said that the Institute collects and keeps records of all reports of suspected side effects of drugs that have manifested themselves in Montenegro, submitted by patients and health workers .
"In addition, all applications from Montenegro are forwarded to the global database, without personal data on patients and healthcare workers," Mugoša explained.
She said that, when necessary, and with the aim of protecting patients, the Institute implements adequate regulatory measures such as new recommendations, precautionary measures, restrictions on application and changes in drug dosage, which can contribute to the improvement of the practice of prescribing drugs, and therefore to a better treatment outcome.
"Before the drug reaches the market, during clinical trials it has been proven that it is safe and effective, which is also confirmed during the drug registration procedure," said Mugoša, noting that, after the drug is put on the market, there is a possibility that notice an unwanted effect that was not noticed before.
She invited citizens to report adverse drug reactions through various mechanisms available on the Institute's portal - www.cinmed.me.
When asked about the increasingly frequent shortages of medicines, Mugoša replied that CInMED does not have jurisdiction in the procedures of supplying the market with medicines, nor their inclusion on the List of Medicines and financing from compulsory health insurance funds.
She said that CInMED is an important link in the health system for creating the conditions for drugs and medical devices to reach the market of Montenegro and that the Institute's actions in accordance with legal deadlines greatly affect the early availability of both innovative and generic drugs.
"Now that we have a good reputation as one of the best regional, and I hope soon, European regulators, we are of the opinion that the pharmaceutical industry will be much more interested in doing business on our market in conditions of transparency, predictability and market competition," Mugoša said. .
Speaking about the strategic goals for the next period, Mugoša said that they adopted key strategic goals aimed at regulatory harmonization, digitization and optimization of processes, as well as the establishment of partnership relations with all factors in the health system.
"Our ultimate goal is to create adequate conditions so that the pharmaceutical industry would be interested in placing its products on our market, which would enable greater availability of medicines and medical devices for patients," Mugoša said.
Further development of the Institute's operations, according to her, should be based on strengthening administrative and technical capacities, as well as increasing the level of competence and further training of employees to perform professional work.
Mugoša announced that the Institute, for the first time since its foundation, will organize an annual conference at the beginning of December called the European perspective of CInMED - cooperation and partnership towards a common goal.
During the conference, as she announced, she will present the Institute's new competences, current developments in regulations in the field of medical devices and organize training in the areas of good practice guidelines in drug distribution and pharmacovigilance, and protection systems against counterfeit and substandard drugs.
"In cooperation with colleagues from the Italian Medicines Agency, we will present the MEDI-THEFT project, which the Institute is implementing in cooperation with EU partners, and whose goal is to prevent the entry of stolen and falsified medicines into the legal supply chain," Mugoša added.
Mugoša said that they are particularly proud of the donor character of the conference, since as the teaching base of the Faculty of Medicine of the University of Montenegro, they have decided to provide the money needed for the establishment of a new, modern laboratory of the faculty through registration fees, in order to improve the quality of practical teaching, as well as scientifically - research work.
She said that the Institute, as a socially responsible institution, tries to help when the opportunity arises, within its capabilities.
"When we all give as much as we can, as a society we have given a lot." I am convinced that every contribution for the welfare of society will be returned many times over," added Mugoša.
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