February 2, 2022
Hello! Happy Lunar New Year! I hope that you are well. I would like to share some of my experiences, recently. As you know, as “Pelin Boran RASC” we are giving services in Regulatory Affairs end to end, as well as in PV, BD, mock-audits with my local team-mates and partners in nearly all regions; CIS, LATAM, Balkan, MENA, GCC, S. Africa, Turkey, APAC as well as North America, UK and EU. And each country in Emerging Markets, it is a different scenario. Especially, countries in markets like CIS region.
Let me remind you the countries in CIS Region. These countries are;
Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Ukraine, and Uzbekistan.
And as you may know there is EAEU which is Eurasian Economic Union since 2014, which is located in Eastern Europe, Western Asia and Central Asia and which has 5 CIS member states including Armenia, Kazakhstan, Kyrgyzstan, Russia and Belarus.
Just like in EU, there are DCP and MRP procedures in EAEU as well. The aim is to get the MA approval in all these countries at the end. (Either individually or simultaneously for all countries).
And it is mandatory to get EAEU GMP approval (for finished product manufacturing plant) from one of these member states before submission. There was previously a period that GMP approvals from other countries (from EU, …) were accepted. However, now it is a requirement to have this approval. And for this step; you need to get the slot for inspection from one of these members and when the GMP approval is received, it will be valid in all 5 members of EAEU.
Especially for Russia there are major differences in the regulation with EU. So, even if you have an MA approval in EU, still there will be major topics to go through according to EAEU requirements as well as local requirements. (On the CMC side as well as on the clinical side, PV side… etc.)
Therefore, our suggestion is to have a strong partner in this region to guide you on the regulation, translation, interactions with the Health Authority as well the other steps to get the approvals, since it is mandatory to have a local agent.
Stay safe and take care!