Abstract
In recent years, it has been observed that more and more health authorities are requesting country specific documents which contain more detailed information than outlined in the Common Technical Documents (CTD) structure agreed within the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This leads to an increased effort for the applicant as the content of the harmonized CTD dossier is no longer sufficient for worldwide submission. This is also the case for submissions in the Eurasian Economic Union (EAEU).
Part 1 of this series dealt with insights and legal framework for the registration and life cycle of medicinal products. This part 2 focuses on an important region-specific requirement in the EAEU, namely the creation of a quality normative document (ND). The ND is a registration relevant document and is used for the quality control testing in the EAEU member states and intended for the post-marketing quality control of the approved drug product.
Correspondence:
Tanja Sorg
Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88400 Biberach
tanja.sorg@boehringer-ingelheim.com
 | Tanja Sorg has a Master’s degree in Pharmaceutical Biotechnology. She is a CMC expert with experience in registration and accreditation of manufacturing facilities, paper-based GMP inspections, tenders and renewals and chemical-pharmaceutical registration dossiers (Module 3) for clinic and market. She also has experience in international CMC regulatory support for marketed products |
