On 29 January, meetings of the Scientific Expert Council and the Scientific and Technical Council were held under the chairmanship of the Director of the Center, Mykhailo Babenko. Based on the results of the expert evaluation of registration materials for medicinal products and clinical trials, the SEC and STC decided to recommend:
in the field of state registration of medicinal products:
- for registration – 12 medicinal products and 5 APIs
- for re-registration – 8 medicinal products and 2 APIs
- introduction of changes to registration materials for medicinal products – 169
- withdrawal from the registration procedure – 1 medicinal products
- withdrawal from review at the expert evaluation stages – 5 medicinal products
- refusals of registration – 1 medicinal products
- technical errors – 4.
in the field of conducting clinical trials:
- for approval of conducting international multicentre clinical trials in Ukraine – 7
- amendments to protocols of international multicentre clinical trials of medicinal products – 7
- withdrawal from the clinical trial expert evaluation procedure (at the applicant's request) – 1
In January, the Center provided the Ministry of Health with 919 expert recommendations in total. During the month, 2 meetings of the Scientific and Expert Council and 4 meetings of the Scientific and Technical Council were held.
