The project establishes new rules for all the stages a medicine goes through before it reaches the patient, from dossier submission to final approval. It also introduces specific deadlines and clearly defined responsibilities for everyone involved in the process.
An important element of the project is the introduction of several types of authorization procedures: general, simplified, accelerated, conditional and joint. They will allow, depending on the situation, to facilitate and accelerate access of medicines to the domestic market, including innovative medicines or in emergency situations.
The authors of the document believe that changes in the procedure of authorization of medicines will strengthen the health care system and create more favorable conditions for the development of the pharmaceutical sector.
“And most importantly, they will ensure patients’ access to quality and reliable medical products,” said Health Minister Emil Ceban.
It is worth noting that the market structure shows a high dependence on imports: about 40% of medicines come from EU countries, followed by India – 20%, Ukraine – 15%, Turkey – 10%, China – 8%, other countries – 7%. This indicates a strong dependence on external supplies and the need to strengthen quality control and international recognition of procedures.
In terms of therapeutic structure, the main share is made up of drugs for the treatment of the digestive system and metabolism – 22%, anti-infective – 20%, cardiovascular – 18%, nervous system – 16%, respiratory system – 14%.
