Journal of Pharmaceutical Sciences and Research
Vol.9, Issue10, P. 1711-1717
Аннотация:
The article considers specifics of arranging introduction of changes in the registration dossier for a registered drug. The authors used the system method to develop and propose charts for the formation of a set of documents in order to introduce changes in the registration dossier for a registered drug in Russia. These charts are compiled with due regard for Russian law and clearly show how to properly compile a set of documents for making the most common changes in the registration dossier. © 2017, Pharmainfo Publications. All rights reserved.
Ключевые слова:
Charts; Drugs registration; Registered drug; Registration dossier for a drug
Article; drug design; drug industry; drug information; drug labeling; drug legislation; drug manufacture; drug packaging; drug quality; drug surveillance program; food and drug administration; pharmacodynamics; pharmacokinetics; pregnant woman; quality control; registered drug; registration dossier; risk management; Russian Federation
Litvinova T. M. Tat`yana Mikhaylovna 1962-
Glazkova I. Yu. Irina Yuryevna 1956-
Kutseva A. P. Anastasiya Pavlovna 1994-
Smy'slova O. A. Ol`ga Aleksandrovna 1977-
Литвинова Т. М. Татьяна Михайловна 1962-
Глазкова И. Ю. Ирина Юрьевна 1956-
Куцева А. П. Анастасия Павловна 1994-
Смыслова О. А. Ольга Александровна 1977-
Arranging introduction of changes in registration dossier for a registered drug in Russia
Текст визуальный непосредственный
Journal of Pharmaceutical Sciences and Research
Vol.9, Issue10 P. 1711-1717
2017
Статья
Charts Drugs registration Registered drug Registration dossier for a drug
Article drug design drug industry drug information drug labeling drug legislation drug manufacture drug packaging drug quality drug surveillance program food and drug administration pharmacodynamics pharmacokinetics pregnant woman quality control registered drug registration dossier risk management Russian Federation
The article considers specifics of arranging introduction of changes in the registration dossier for a registered drug. The authors used the system method to develop and propose charts for the formation of a set of documents in order to introduce changes in the registration dossier for a registered drug in Russia. These charts are compiled with due regard for Russian law and clearly show how to properly compile a set of documents for making the most common changes in the registration dossier. © 2017, Pharmainfo Publications. All rights reserved.