DOC // Procedure for authorizing medicines to be streamlined: faster access to treatments for patients
The procedure for authorizing and placing human-use medicines on the market will be streamlined and aligned with European standards. The new provisions will reduce administrative burdens and will allow patients to gain faster access to safe, effective, and high-quality medicines.
The Regulation on the authorization of human-use medicines was published today in the Official Journal. The document sets clear rules for all stages a medicine goes through before reaching patients – from the submission of the application file to final approval. It also introduces clear deadlines and well-defined responsibilities for all those involved in this process.
An important element of the project 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 access of medicines to the domestic market, including for innovative treatments or in emergency situations.
According to the authorities, changes in the medicine authorization procedure will strengthen the health system and create better conditions for the development of the pharmaceutical sector.
The Government Decision on the procedure for authorizing the placing on the market of human-use medicines will enter into force one month after the date of its publication in the Official Journal of the Republic of Moldova.
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