The World Health Organization (WHO) will provide, over the next 18 months, technical assistance to the Ministry of Health and the Agency for Medicines and Medical Devices (AMDM) for the modernization of key processes in the sector. The initiative is financially supported by the European Union.
According to the WHO Office in Chisinau, the support will primarily focus on improving the process of alignment with the EU acquis, by updating the legislative and procedural framework. “These changes will ensure transparency, predictability and uniformity in the regulation of medicines and medical devices,” is stated in a press release.
Another direction aims at strengthening the professional skills of the AMDM staff. “WHO will provide specialized training, exchange of experience and technical mentoring, so that AMDM is better prepared to respond to the challenges related to the verification of the safety and effectiveness of medical products and market surveillance,” the cited source specifies.
The project also includes support for digitization and interoperability, to facilitate the connection of institutions in the country to relevant EU platforms, such as EudraVigilance – the European system for reporting adverse reactions to drugs – or EUDAMED, the European database for medical devices.