Registration deadlines for medicinal products will be shortened in Armenia.

ArmInfo. Drug registration deadlines in Armenia will be shortened. At a meeting on October 29, the government approved amendments to the Law "On Medicines" and a package of related documents.

The draft's rationale notes that the initiative proposes setting the drug registration deadline to 10 calendar days instead of the current 31 calendar days, and excluding the full drug dossier in CTD format and the assessment report prepared for drug registration in the reference country from the required package of documents.

According to the package, it is proposed to establish bilateral or multilateral recognition of decisions of two or more regulatory bodies under the conditions established by law or international agreements, including within the EAEU. At the same time, drug registration under a simplified recognition procedure should not lead to a reduction in state control over the safety, quality, and efficacy of drugs.