Regulatory Update on eSubmissions in Balkans

¹RA & PV Manager, Bionika Pharmaceuticals, Skopje, North Macedonia

²Faculty of Medical Sciences, Goce Delcev University, Stip, North Macedonia

*Corresponding author: Marjan Dzeparoski, RA & PV Manager, Bionika Pharmaceuticals, Skopje, North Macedonia and Faculty of Medical Sciences, Goce Delcev University, Stip, North Macedonia, Tel: +38970338858, E-mail: [email protected].

Received Date: March 15, 2024

Published Date: April 01, 2024

Citation: Dzeparoski M. (2024). Regulatory Update on eSubmissions in Balkans. Mathews J Pharma Sci. 8(1):26.

Copyrights: Dzeparoski M. © (2024).

ABSTRACT

Electronic submissions of medicinal products are becoming mandatory for all types of Applications. Regional regulatory aspects are moving towards global electronic submissions/eCTD worldwide. The readers will get an indepth look at regulation compliance from the emerging markets like North Macedonia, Serbia, Montenegro, Bosnia and Herzegovina, Albania and Kosovo and keep up to date on country-specific environments concerning submissions of medicinal products and medical devices.

Keywords: Regulation, Electronic Submissions, Medicinal Products, Medical Devices, Harmonization.