Industry and EMA officials are reporting that for products marketed both in the EU and in Russia, Russian regulatory officials prefer release testing to be done in the EU.
The issue of release testing for drug products going to Russia received attention during a panel discussion at a “European GMPs and the Role of the QP” conference in late June in Bethesda, Maryland, sponsored by the European Compliance Academy (ECA) and the European Qualified Persons (QP) Association.
A conference attendee explained that for a product her firm markets in Russia, testing is done by the firm in Europe and the QP transfers the test results to the US, where the product is released.
“Currently,” she explained, “Russia requires that the testing is done in Europe. That is why the QP gives me a test certificate. But they do not require the QP to release it as European member states would.”
EMA Compliance and Inspection Scientific Administrator Dimitrios Catsoulacos explained that Russian officials have developed an increasing comfort level with European regulatory agencies – in particular, the European Directorate for the Quality of Medicines (EDQM).
“I just recently attended a conference in Russia” where Russian regulators were present, Catsoulacos commented. “It was the first time that somebody from EMA had actually interacted with them. They have very good interactions with EDQM, which is part of the European Council and not the EMA.”
At the conference, Catsoulacos learned that the Russian regulatory agency prefers that products coming from abroad either come through Europe or have product testing and documentation come from there, especially for vaccines, biological and biotech products.
“Basically, for any product that is marketed in both Europe and Russia, they would require the documentation from the EU because it is easier for them to accept,” the EMA official reported. “If the product is not marketed in Europe, then they will do their own national release. Those are the rules that they have established for release of products in their own market.”
