Drug clinical review addendum (DCRA) – a document which confirms a drug efficacy and safety throughout a marketing authorization period and necessary in submission for a termless drug re-registration.
In accordance with Order of MoH dated 23.07.2015 №460 “On Introduction of Amendments to Procedures for expertise of drug registration materials submitted for state registration (re-registration) and expertise of materials for introduction of amendments to registration materials over the validity period of a marketing authorization and approval Procedures of material validation attached to the application for state registration of certain medicinal products according to their volume” in dossier clause 2.3, DCRA should be submitted.
DCRA contains the following information:
— drafts of updated instructions, summary of product characteristics;
— tables with serious adverse reactions;
— summary of significant safety and efficacy issues;
— review of significant literature publications;
— risk assessment;
— benefit assessment;
— benefit/risk assessment.
Together with DCRA, a clinical expert application is also submitted.
Specialists of our company collaborate with the leading clinical experts in various areas.
Execution term: 2-3 weeks.
As well, specialists of our company will help you in registration, see in sections Drug registration and Development of pharmacovigilance system, see more details in section Pharmacovigilance.