publication . Article . 2019

Post-approval Variations to Dossiers for Vaccines: Analysis of Regulatory and Methodological Approaches Used in the Russian Federation and Abroad

Shevtsov, V. A.; Olefir, Yu. V.; Merkulov, V. A.; Bondarev, V. P.; Indikova, I. N.; Evreinova, E. E.; Rukavishnikov, A. V.; Khantimirova, L. M.; Gorenkov, D. V.;
Open Access
  • Published: 25 Mar 2019
  • Publisher: SCEEMP
The management of post-approval changes to registration dossiers for medicinal products is one of the most important factors for ensuring sustainable quality, safety and efficacy of medicines. Competent authorities that use the module format of the registration dossier, i.e. the regulatory authorities of the European Union, USA and other members of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and the Eurasian Economic Union (EEU), issue guidelines on changes to registration dossiers for pharmaceuticals and biologicals (immunological products). Vaccines (finished dosage forms) and vaccine antigens ...
Persistent Identifiers
free text keywords: quality evaluation, quality standards, changes, variations, registration dossier, master-file, vaccine antigen, vaccine, Business, Legislation, Economic union, Master file, Vaccine antigen, Public administration, Guideline, European union, media_common.cataloged_instance, media_common, Health care, business.industry, Federal state, lcsh:Medicine (General), lcsh:R5-920
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