In Ukraine, the implementation of the international electronic standard for submission of registration materials for the registration of medicinal products – eCTD (electronic Common Technical Document) continues. Currently, all companies submitting documents for new drug registrations are required to do so in the eCTD format. About this informs press office of the Ministry of Health.
This requirement is enshrined in the Law of Ukraine “On Medicinal Products” No. 2469-IX. From now on, all documents are submitted in a unified structure and in a form convenient for experts. This makes it easier to review materials, review them faster, and track changes more efficiently.
“The transition to the international eCTD format is another important step in the digitalization of the pharmaceutical sphere and approximation to European standards. It allows making the process of drug registration more transparent and understandable. Despite the challenges of wartime, thanks to the coordinated interaction of all stakeholders, the introduction of eCTD in Ukraine took place much faster than in other European countries.”, – emphasized Maria Karchevych, Deputy Minister of Health for Digital Development.
According to the State Expert Center of the Ministry of Health, 72 dossiers in eCTD format have already been submitted at the beginning of the mandatory stage, of which:
- 18 — according to the procedure of primary registration of medicinal products
- 5 — for re-registration
- 49 — on making changes to the registration materials
In addition, 343 electronic applications were received through the new functionality of the “Single Window” (applicant’s office).
Electronic Common Technical Document (eCTD) is an international standard for the transfer of technical and regulatory documentation in the process of registration of medicinal products. It was developed by the International Conference for Harmonization (ICH) with the aim of unifying the format of information exchange between the pharmaceutical market and regulators. Today, eCTD is successfully used in the EU, USA, Australia, Canada, Japan, the Persian Gulf countries and other countries of the world.
