The Eurasian Economic Union (EAEU) has worked to harmonise rules for medicinal products across its member states, including common Good Clinical Practice rules. For sponsors, this can simplify multi-country planning, but national procedures for submissions, ethics review and import of investigational products still differ.
Plan submissions country by country
Even where the underlying rules are aligned, timelines, document formats and local language requirements vary. Building a country-level submission calendar early prevents surprises later.
Mind the logistics
Customs and import permits for investigational products and biological samples are a frequent source of delay. Engaging a local partner with established depot and courier relationships protects your supply chain.
Work with local expertise
A regional CRO can interpret the requirements in practice, not just on paper. Our regulatory affairs team supports sponsors from first strategy discussions through ongoing amendments.
This article is general information, not legal or regulatory advice. Always confirm current requirements with the relevant authorities.
Ready to plan your next study?
Tell us about your programme and we will respond with a tailored proposal.