Regulatory Challenges in the CIS and Russia - TOPRA In CEE WebinarNovember 22, 2023
Optimizing Dossier Preparation in Accordance with EAEU Guidelines
Pursuant to the EAEU regulations registration dossiers are mandatory to be submitted in electronic format from the end of 2025. In this case outsourcing of registration activities can bring big benefits to pharmaceutical companies that plan to access the common markets of the EAEU countries.
Currently, more than 14.5 thousand drugs are registered in the Russian Federation, and 40.5 thousand in the EAEU. Preparatory work takes from 6 to 8 months, including medical translations, patient information leaflets (PILs) readability user testing, eCTD publishing, electronic submissions, etc.
“There is a great need for qualified specialists in the EAEU who have sufficient experience and can competently plan and implement a project to bring dozens and sometimes hundreds of dossiers in line with the EAEU regulations. In addition to salaries, pharmaceutical companies will have to pay taxes, provide the equipment. After registration is completed, the question will arise - where to employ new staff,” noted Olga Zvonareva, RA Director CIS, Inpharmatis Group.
A clearly defined plan, assessment of the products portfolio, as well as available and necessary resources will help to optimize the process. Particular attention should be paid to the new processes established by the EAEU requirements. Partial outsourcing enables simplifying and speeding up registration processes. For example, the Inpharmatis Group provides a full cycle of Regulatory Affairs, including the creation of a dossier in eCTD format and its submission to health authorities on behalf of the applicant in accordance with the EAEU requirements.
Inpharmatis Group has been operating for over 15 years in the EU, CIS, and EAEU countries and offers pharmaceutical companies a full range of services for pharmaceutical product lifecycle management. We have successfully completed a number of rather complex projects, including registration of orphan drugs, vaccines, substances in the EAEU member states.
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