Snapshot

The Expedited Review pathway has been developed by the State Service of Ukraine on Medicines and Drugs Control (SMDC) of Ukraine.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Specialized expert evaluation is conducted not more than 45 working days from the moment of submitting the registration dossier. This period does not include: the period of assessment of the Application and the registration form; payment of the government levy and receiving the payment confirmation; preliminary expert evaluation of completeness of the dossier for registration; the time required for the Applicant to respond to the observations; final actions after expert evaluation (verification/proofreading of drafts of the registration certificate and its addenda); period of signing the Order of the MOH on registration of the medicinal product. The above actions take an average of 2 to 4 months, and, accordingly, extend the resulting period for registration.