Better access to treatments: Government modernizing medicine authorization system
Government today approved a draft decision on the procedure for authorizing and marketing of medicinal products for human use. The new provisions will reduce administrative burdens and enable patients to gain faster access to safe, effective and high-quality medicines.
The draft establishes clear rules for all the stages a medicine goes through before reaching patients – from the submission of the application to the final approval. It also introduces clear timelines and well-defined responsibilities for everyone involved in this process.
An important element of the draft is the introduction of several types of authorization procedures: general, simplified, accelerated, conditional, and collaborative. Depending on the situation, these will facilitate and speed up the access of medicines to the domestic market, including for innovative treatments or in emergency situations.
The changes in the medicine authorization procedure will strengthen the health system and create better conditions for the development of the pharmaceutical sector.
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