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14 new medicinal products recommended for registration and 2 clinical trials for approval – results of the Scientific Expert Council (SEC) and Scientific and Technical Council (STC) of 09.02.2023

10.02.2023 1623 views

Following the expert review of registration materials, by decision of the commission of the scientific-technical and scientific-expert councils of the Center of 09 February 2023, more than 270 recommendations were provided to the MoH of Ukraine.

In particular:

  • before registration of medicinal products – 14
  • for re-registration of medicinal products – 9
  • to re-registration of substances – 3
  • introduction of changes to registration materials for medicinal products – 221
  • protocols of international multicenter clinical trials of medicinal products – 1
  • protocols of clinical trials of medicinal products from domestic manufacturers – 1
  • amendments to protocols of international multicenter clinical trials of medicinal products – 22, of which for the treatment of Covid-19 – 1.

Among those recommended for registration are analgesics, antibacterial, anti-inflammatory, lipid-lowering, pain-relieving, antiviral and other agents.

It is also recommended to conduct 2 KV – for the treatment of patients with acute exacerbation of schizophrenia and hypertension.