Electronic Common Technical Document
With the transition to a single market for circulation of pharmaceuticals for human use of the EAEU, the member states of the Union have a task to create a single information system that allows to submit documents to the regulatory authority, as well as to evaluate the registration dossier electronically. The participants of the circulation market also adopted the idea of switching to the system of electronic document management and began to actively implement the so-called automated workplace for employees of the regulatory office. sector. In this regard, it is interesting to study software products for the formation of an electronic dossier and support of the procedure for registration of medicines (drugs).
This kind of software is intended for use by development companies, distributors, production sites, consulting companies and is called Regulatory Information Management System (RIMS). RIMS systems are particularly convenient for large companies with a large number of projects in different regions. In Russia, the standard Excel product from the Office is mainly used. However, this product does not take into account the specifics of the developed documentation and does not allow to carry out work at a professional level.
Experts of the FSBI “Scientific Center for Examination of Medical Devices” considered various digital systems for the formation of electronic dossier and maintenance of the registration procedure of drugs:
|Comparison of the functions of software products for the formation of the registration dossier*|
|Product name/country||Description of the drug
|Formation of the dossier||Research management||Regulatory action planning|
|Oracle Argus/ USA||+||+||+||+|
|Flex Databases/ USA||+||–||+||+|
|MC Excel (and other table editors)/USA||Conditionally (can be used in manual mode)||–||Conditionally (can be used in manual mode)||Conditionally (can be used in manual mode)|
* Accroding to K.A. Koshechkin, E.M. Rychikhina, Yu.V. Olefir.
Of the above products for the Russian Federation are localized: Flex Databases, Data MATRIX (within the framework of clinical trials), Lexsoft, 1C: CTD, for EAEU – Data MATRIX (within the framework of clinical trials), Leksoft, 1C: CTD.
EXTEDO SOLUTIONS is widely used in Europe and the USA. The developer company offers a wide range of products and services. Among the software, there are three main groups — ESUBMANAGER, EURSVALIDATOR, ECTDMANAGER.
ESUBMANAGER allows the team to jointly edit the documentation of the registration dossier according to the specifics of the region.
Fig. Interface of ESUBMANAGER.
EURSVALIDATOR is necessary for the validation of the dossier for compliance with the requirements of a specific region.
ECTDMANAGER helps in designing, reviewing, validating and dossier publishing. In addition, the software has the function of submission tracking in different regions, which is very convenient for a large amount of work.
- К.А. Кошечкин, Е.М. Рычихина, Ю.В. Olefir. Цифровые системы для формирования электронного досье и сопровождения процедуры регистрации лекарственных средств. Ремедиум, 2018, 10
- К.А. Кошечкин. Практические рекомендации по применению цифровых систем для подготовки регистрационного досье в формате CTD в рамках Правил ЕАЭС
©Beawire – October 2019.