Open AccessCHANGE MANAGEMENT OF DRUG PRODUCTS REGISTRATION CONDITIONS: NEW ICH Q12 GUIDELINE
Author(s) -
А П Мешковский,
Пятигорская Наталья Валерьевна,
Мешковский Андрей Петрович,
В. В. Береговых,
Береговых Валерий Васильевич,
Ж И Аладышева,
Аладышева Жанна Игоревна,
V. V. Belyaev,
Беляев Василий Викторович,
Alexander M. Pyatigorsky,
Пятигорский Александр Михайлович,
N. S. Ivashechkova,
Ивашечкова Наталья Сергеевна
Publication year - 2018
Publication title -
vestnik rossijskoj akademii medicinskih nauk
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.122
H-Index - 15
eISSN - 2414-3545
pISSN - 0869-6047
DOI - 10.15690/vramn998
Subject(s) - guideline , harmonization , business , conformity assessment , conformity , traceability , product (mathematics) , process management , quality (philosophy) , risk analysis (engineering) , product lifecycle , technical standard , protocol (science) , accounting , operations management , medicine , new product development , engineering , computer science , marketing , political science , alternative medicine , law , philosophy , mathematics , software engineering , pathology , acoustics , operating system , geometry , epistemology , physics
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 introduced by the draft guideline ICH Q12: categorization of post-approval changes, established conditions, post-approval change management protocol, and drug product lifecycle management.