Drug clinical review addendum (DCRA) \u2013 a document which confirms a drug efficacy and safety throughout a marketing authorization period and necessary in submission for a termless drug re-registration.
\nIn accordance with Order of MoH dated 23.07.2015 \u2116460 \u201cOn 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\u201d in dossier clause 2.3, DCRA should be submitted.
\nDCRA contains the following information:
\n\u2014 drafts of updated instructions, summary of product characteristics;
\n\u2014 tables with serious adverse reactions;
\n\u2014 summary of significant safety and efficacy issues;
\n\u2014 review of significant literature publications;
\n\u2014 risk assessment;
\n\u2014 benefit assessment;
\n\u2014 benefit\/risk assessment.
\nTogether with DCRA, a clinical expert application is also submitted.
\nSpecialists of our company collaborate with the leading clinical experts in various areas.
\nExecution term: 2-3 weeks.
\nAs 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.<\/p>\n","protected":false},"excerpt":{"rendered":"
Drug clinical review addendum (DCRA) \u2013 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 \u2116460 \u201cOn Introduction of Amendments to Procedures for expertise of drug registration materials submitted for state registration (re-registration) \u0447\u0438\u0442\u0430\u0442\u044c \u0434\u0430\u043b\u044c\u0448\u0435…<\/a><\/p>\n","protected":false},"author":1,"featured_media":398,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[6],"tags":[],"class_list":["post-245","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-farmakonadzor"],"translation":{"provider":"WPGlobus","version":"3.0.0","language":"en","enabled_languages":["uk","ru","en"],"languages":{"uk":{"title":true,"content":true,"excerpt":false},"ru":{"title":true,"content":true,"excerpt":false},"en":{"title":true,"content":true,"excerpt":false}}},"acf":[],"_links":{"self":[{"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/posts\/245","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/comments?post=245"}],"version-history":[{"count":5,"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/posts\/245\/revisions"}],"predecessor-version":[{"id":501,"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/posts\/245\/revisions\/501"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/media\/398"}],"wp:attachment":[{"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/media?parent=245"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/categories?post=245"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/tags?post=245"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}