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Registration of Active Pharmaceutical Indredients (API) in Russia

EAEU GMP certification


For the registration (“inclusion to state register of medicines”) of a commercial API in Russia, it is also required to present EAEU GMP certificate for the API manufacturing site. Before 2021, Russian GMP conclusions (certificates) were required for the API registration, now the national API registration procedure in Russia requires EAEU GMP certificate.

EAEU GMP certification is governed by the Resolution № 77 dd. Nov 03, 2016 of the Council of the Eurasian Economic Commission "On Adoption of the Rules of Good Manufacturing Practice of the Eurasian Economic Union".

The federal authorized body, Ministry of Industry and Trade (MIT) of the Russian Federation had officially empowered Federal State Institution “State Institute of Drugs and Good Practices” ("FSI SID&GP")  as the only dedicated institution that performs EAEU GMP inspections and GMP certification expertise.

Historically, Pharegis LLC obtained first-ever Russian GMP conclusion for Chinese APIs manufacturer back in 2016, it was the second ever Russian GMP certificate among all Chinese pharmaceutical manufacturers.

EAEU GMP inspection: scope and procedure

The inspections of API manufacturing site are performed by team of 2 (rarely 3) duly authorized inspectors of FSI SID &GP, taking 3-4 full business days (usually 9 am – 5 pm) for each manufacturing site, having 45 minutes lunch break as well as 2 coffee breaks.

As for the typical scope of EAEU GMP inspection, here is a sample of real anonymized EAEU inspection plan with areas that it covers and documents to be evaluated.

EAEU GMP inspection: interpreters team

The regulations require availability of the interpreters provided by the site or applicant, each interpreter is dedicated to its own inspector since the inspectors work in parallel. Having managed dozens of Russian and EAEU GMP inspections, Pharegis usually provides team of professional interpreters experienced in pharmaceutical manufacturing, QMS and GMP regulations, and we have outstanding feedback from all inspectors (including the Head of FSI SID &GP himself) concerning the interpreting performance.

EAEU GMP: expected challenge, statistics and options proposed by Pharegis

EAEU GMP inspections are more challenging than EU ones, most manufacturers compare overall challenge of EAEU inspections to Brazil (Anvisa) ones. As per the statistical data since 2016, 1/3 of overall GMP applications resulted in GMP certification refusal due to sum of GMP non-compliance observations and/or follow-up CAPA inadequacy.

Pharegis can minimize the risk of GMP certification refusal to zero by adding our procedure of thorough pre-inspection GMP audit that is second to none in Russia and EAEU. Contact us to get the details, we also offer that service as a standalone one.

EAEU GMP certification timeline

Overall duration of EAEU GMP certification is 6-12 months, depending on the queue of applicants, complexity of APIs manufactured by the site (sterile/biotech etc), as well as chosen services options.

To optimize the registration timeline as much as possible, we perform both GMP certification and API  registration in parallel, where the EAEU GMP certificate will be required only at the finishing stage of the API registration.

So EAEU GMP certification will NOT prolong the overall timeline of the registration of you API(s).

We can focus on a chosen part of the whole project – either GMP part or API registration part if you would like to divide the project with any 3rd party for some reason (as per our experience that is more complex in terms of logistics, data integrity, overall timeline optimization and costs).

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