Snapshot

The Expedited Registration pathway has been developed by the National Center for medicines, medical devices and medical equipment expertise of Kazakhstan.

This pathway accelerates the regulatory review process.

At all stages of the expedited procedure for the examination of the medical agent carried out in a period not exceeding one hundred and twenty calendar days, including: (1) primary expertise - not more than twenty calendar days; (2) analytical expertise to fifty days; (3) Specialized Pharmacopeia expertise - not more than forty calendar days, including confirmation of the authenticity of the translation of marking layouts packaging, labels, stickers (not more than two working days); (4) special pharmacological expertise - not more than forty calendar days, including verification of the authenticity or translating instructions for medical use (not more than ten calendar days); (5) a conclusion on the safety, efficiency and quality of medical agents, the draft outcome document examination of Medical Agents - not more than ten calendar days. With the exclusion of one stage of the remaining stages of the examination dates are stored. The terms of the examination of the medical agent does not include the time to fill the incompleteness of the registration dossier submitted by the applicant of documents and materials on request at any stage of the examination, as well as the organization of the assessment of the conditions of production and quality assurance system for enterprise-manufacturer, requests expert committees and harmonization applicant outcomes.