About 500 recommendations on re-registration of medicines and amendments to registration materials – results of the week's STC meeting.
Following the meeting of the Scientific and Technical Council of the Center on the review of registration materials submitted for state expert evaluation for their registration/re-registration, amendments to registration materials, and materials on clinical trials of medicinal products in Ukraine, it was approved to recommend to the Ministry of Health of Ukraine:
- for re-registration for an unlimited period – 16 medicinal products
- to registration of substances – 1
- to re-registration of substances – 4
- amendments to registration materials (regarding quality, safety/efficacy and pharmacovigilance, administrative, etc.) – 430 medicinal products
- amendments to the protocols of international multicenter clinical trials – 40, including those concerning coronavirus disease – 1.
