Photo by Artem Beliaikin on Unsplash
The Eurasian Economic Union (EAEU) pharma market is projected to reach a staggering USD 60 billion by 2035. To ensure the quality and safety of medicines within this growing market, regulatory authorities are implementing stricter guidelines. This article explores the latest updates to EAEU GMP and registration procedures and provides a roadmap for navigating the compliance process.
According to the union’s “Own Center of Economic Power” scenario, the EAEU GDP is estimated to grow at an additional 2,9% by 2030. This growth will also be driven by intra-EAEU trade, with a potential increase of 2,8% by 2030.
Figure 1. EAEU Pharma Market: Market Shares and Latest Trends
EAEU GMP Updates and Compliance Timeline
The Eurasian Economic Commission (EEC) is actively revising the EAEU GMP regulations. December 31st, 2024, looms as a crucial deadline for pharma companies operating within the EAEU, including Russia, Armenia, Belarus, Kazakhstan, and Kyrgyzstan. By this date, all manufacturers must ensure their GMP compliance and dossier documentation align with the latest EAEU regulations. Keep in mind that the deadline for medical devices has been extended until December 31, 2025.
Another significant update planned for the near future is the introduction of dedicated sections for the production of high-tech medicines. Additionally, the existing regulations for sterile drug manufacturing are undergoing modernization.
Finally, the Council of EEC amended the Rules for Registration and Examination of Medicinal Products for Medical Use (Decision No. 114), which came into force on December 20, 2023, to simplify the harmonization procedure for drug registration. Here are the key changes applicants need to be aware of for registering drugs with the EAEU guidelines:
- Applicants can now use the CTD structure for the eCTD dossier (electronic Common Technical Document).
- Certain sections of Module 1 are no longer required for initial registration applications (e.g., contracts with manufacturers).
- Applicants can justify not providing some information initially, but may be requested later by the authorized body.
- Drugs that have been available in the reference country for over 5 years can qualify for an unlimited Russian registration certificate.
- More detailed requirements are specified for various sections across Modules 1, 2, 3, 4 and 5.
How to Achieve EAEU GMP and Registration Compliance
Figure 2. CPC EAEU GMP and Registration Compliance Process
Here’s a breakdown of the key steps according to our experience:
EAEU GMP Certification (2-3 months of preparation):
- Pre-Audit and GAP analysis Report: We conduct a comprehensive video pre-audit for 4-5 days to identify any gaps between your current practices and EAEU GMP requirements.
- CAPA Plan Development: Based on the pre-audit findings, we help you develop a Corrective and Preventive Action (CAPA) plan to prepare you for the inspection.
- EAEU Inspection Readiness: We provide ongoing support during the application and government inspection.
EAEU Registration (10-12 working days of preparation):
- Dossier Check and GAP Analysis: Our team meticulously reviews your registration dossier to ensure it adheres to the latest EAEU CTD format.
- Application Assistance: We guide you through the application process, ensuring all necessary documentation is complete and accurate (1-2 video calls). Optionally, we can support you with the CAPA plan.
- Dossier Submission and Support: We facilitate the smooth submission of your registration dossier to the relevant EAEU authorities and provide ongoing support throughout the review process.
Capitalize on the EAEU’s Booming Pharma Market
The EAEU’s pharma market is experiencing robust growth, fueled by increasing intra-EAEU trade and ongoing integration efforts. This presents a unique opportunity for companies willing to enter the region, given that their registration dossier is in line with EAEU GMP standards.
We at CPC support our clients with more than 25 years of experience in EAEU GMP audits and inspections. With our expertise, you can achieve EAEU GMP compliance and gain access to this rapidly growing pharma market. Contact us today to discuss your EAEU compliance strategy.
