Change management of drug products registration conditions: New ICH Q12 guideline
Пятигорская Н. В., Мешковскии А. П., Береговых В. В., Аладышева Ж. И., Беляев В. В., Пятигорскy А. М., Ивашечкова Н. С.
Вестник Российской академии медицинских наук
Т. 73, Вып. 3, С. 181-189
Опубликовано: 2018
Тип ресурса: Статья
Аннотация:
Introduction of amendments to the registration dossier is the responsibility of the marketing application holder (MAH). Increased knowledge on pharmaceuticals, its manufacturing and control processes can reduce the number of documents submitted to the regulatory authorities. The existing requirements establishing the procedure for the introduction of amendments differ in terms of change classification, period of notification of regulatory authorities, ways of conformity validation of pharmaceutical properties, etc. ICH proposed draft guideline Q12 «Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management» which covers the problem of harmonization of regulatory approaches to the changes provided in the «Quality» section of CTD during the commercial phase of drug life cycle. The new guideline can be considered as the continuation and elaboration of previous ICH documents. The article provides explanations on the main provisions and regulatory mechanisms int
Ключевые слова:
Drug product lifecycle management; Established conditions; ICH Q12 guideline; Post-approval change management protocol
Язык текста: Русский
ISSN: 0869-6047
Пятигорская Н. В. Наталья Валерьевна 1965-
Мешковскии А. П.
Береговых В. В. Валерий Васильевич 1942-
Аладышева Ж. И. Жанна Игоревна 1967-
Беляев В. В.
Пятигорскy А. М.
Ивашечкова Н. С.
Pyatigorskaya N. V. Natal`ya Valeryevna 1965-
Meshkovskii A. P.
Beregovy'kh V. V. Valerij Vasilyevich 1942-
Alady'sheva Zh. I. Zhanna Igorevna 1967-
Belyaev V. V.
Pyatigorsky A. M.
Ivashechkova N. S.
Change management of drug products registration conditions: New ICH Q12 guideline
Текст визуальный непосредственный
Вестник Российской академии медицинских наук
Издательство "Педиатръ"
Т. 73, Вып. 3 С. 181-189
2018
Статья
Drug product lifecycle management Established conditions ICH Q12 guideline Post-approval change management protocol
Introduction of amendments to the registration dossier is the responsibility of the marketing application holder (MAH). Increased knowledge on pharmaceuticals, its manufacturing and control processes can reduce the number of documents submitted to the regulatory authorities. The existing requirements establishing the procedure for the introduction of amendments differ in terms of change classification, period of notification of regulatory authorities, ways of conformity validation of pharmaceutical properties, etc. ICH proposed draft guideline Q12 «Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management» which covers the problem of harmonization of regulatory approaches to the changes provided in the «Quality» section of CTD during the commercial phase of drug life cycle. The new guideline can be considered as the continuation and elaboration of previous ICH documents. The article provides explanations on the main provisions and regulatory mechanisms int