In order to improve qualifications, over the five months of the current year three training seminars were held for experts and consultants of the KEH, at which the following issues related to the procedures for registration/re-registration of medicinal products were discussed:
- Assessment of immunogenicity when using biosimilars;
- Specifics of conducting the expert evaluation of registration materials for a similar biological medicinal product (biosimilar);
- Registration of medicinal products based on a full dossier and of fixed-dose combination medicinal products. Specifics of the procedure and requirements for preparing the registration dossier;
- Registration of medicinal products (vaccines and blood products) with a full (stand-alone) dossier. Features of the procedure and requirements for preparing the registration dossier;
- Specifics of submitting the registration dossier for a generic, hybrid medicinal product in accordance with the requirements of MoH order No. 460;
- Specifics of submitting the registration dossier for traditional and homeopathic medicinal products;
- Registration of medicinal products under the accelerated procedure;
- Instructions for medical use – as a summary of the registration dossier.
Such seminars allow all experts to exchange opinions and discuss current issues that arise during the review of registration materials, which makes the procedures more transparent.
