
Especially significant medicinal product.
At the beginning of October, Recommendation No. 26 “On guidelines for assessing the special significance of medicinal products for public health for the purpose of conducting accelerated examination during their registration” was published on the EAEU legal portal.
The Guide contains recommendations for drawing up an application to recognize a medicinal product as particularly significant for public health and preparing the necessary justification.
According to the document, the justification for the special significance of the drug must reflect:
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clinically significant therapeutic advantages compared to existing methods of providing medical care in the EAEU member states;
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information on the scope of preclinical and clinical studies of the medicinal product;
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the need of the healthcare system for the introduction into clinical practice of a new drug for the treatment and prevention of the target nosology and the severity of the disease (condition) in question;
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confirmation of the therapeutic value established within the clinical studies, as well as an assessment of the sufficiency and representativeness of the attached clinical study results.
Along with the justification document, sources with their translation into Russian must be attached to the registration dossier.
If a drug is declared to be of particular importance for several indications, an assessment must be carried out for each indication.
The expert committee will assess the significance of the drug according to 4 criteria arising from the information required to be provided in the justification (Appendix 1 to the Recommendation):
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Health care need (maximum / moderate / none);
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Severity of the disease (unconditional / present / conditional);
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Therapeutic value (maximum / important / none);
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Weight of evidence (convincing / relatively convincing / insufficient evidence).
The appeal is reviewed within 30 working days.