How drug registration works in the EAEU, the European Union, and the US, and how FDA and EMA procedures differ from EEC rules
A company that simultaneously submits a dossier to Moscow, Amsterdam, and Silver Spring quickly discovers that identical procedures do not exist. The exact same medicinal product follows three distinct regulatory pathways, because in each system a different body makes the decision, under its own rules: the EAEU reference state decides on its own, the European Commission acts on the recommendation of a specialized scientific committee, and the FDA approves a drug single-handedly.
The years 2025 and 2026 made this divergence particularly visible. On 31 December 2025, the deadline for aligning national marketing authorization dossiers with Union rules expired in the EAEU. On 1 October 2025, the EU and the US expanded mutual recognition of manufacturing site inspections. On 9 March 2026, new Good Clinical Practice (GCP) rules entered into force across the Union. For a regulatory affairs manager planning a simultaneous product launch across all three markets, these dates are a working calendar.
Three regulatory traditions that diverged for decades
The FDA has operated since 1938 as a direct-action federal agency. The FDA Commissioner approves or rejects an application independently, and this decision is binding across the entire US market. This arrangement took shape from the Agency’s founding: one body makes the decisions, and the fee system under the Prescription Drug User Fee Act (PDUFA) was introduced to give the Agency the resources to work quickly.
The European Union was built differently. The EMA, whose headquarters relocated to Amsterdam following the UK’s withdrawal from the EU, does not issue marketing authorizations itself. The Agency prepares a scientific recommendation through the Committee for Medicinal Products for Human Use (CHMP), while the formal, legally binding approval is issued by the European Commission. This reflects the status of the EU as a union of sovereign states: member states delegated scientific evaluation to Brussels and retained their own national healthcare systems.
The EAEU is considerably younger than both systems. The Treaty on the Eurasian Economic Union was signed in 2014, and unified drug registration rules became operational for new medicinal products in 2016 under Decision of the Council of the Eurasian Economic Commission (EEC) No. 78 dated 3 November 2016, «On the Rules for Registration and Examination of Medicinal Products for Human Use» (hereinafter — Decision No. 78). Before that, Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan registered drugs each under their own national rules. Expert review in the EAEU is carried out by the national competent authorities of the member states rather than by a supranational body, so the Union combines unified rules with distributed national assessment.
The transition from national rules to Union-wide rules spanned nearly a decade and concluded only recently. Products submitted for registration in member states before 1 July 2021 (for Russia, this cut-off came earlier, on 31 December 2020) could be registered, at the applicant’s choice, either under national legislation or directly under Decision No. 78. For applicants who chose the national route, a common deadline was set: dossiers had to be aligned with Union requirements by 31 December 2025. EEC Council Decision No. 34 of 22 May 2025, softened the consequences for late filers: if the alignment application was submitted on time, the national marketing authorization remains valid for the entire review period. The national and Union regimes coexisted in parallel for nearly ten years before finally converging into a single procedure for most medicinal products by the end of 2025.
The three systems in 2026
The divergence between the systems shows up first in who makes the final decision. In procedures where an approval can be extended to several countries, the first country is called the reference state, and the countries that recognize its decision afterward are called states of recognition.
Table 1. Institutional framework
| Parameter | FDA (USA) | EMA (EU) | EAEU |
|---|---|---|---|
| Structure | Centralized federal agency | Network of national competent authorities coordinated by the EMA | Supranational rules implemented by national competent authorities |
| Decision maker | FDA Commissioner | European Commission, based on CHMP’s scientific recommendation | Competent authority of the reference state and each state of recognition |
| Legal basis | Federal Food, Drug, and Cosmetic Act | Directive 2001/83/EC and Regulation (EC) No 726/2004 | Treaty on the EAEU and Decision No. 78 |
| Dossier language | English | Official EU languages for labeling and the Summary of Product Characteristics (SmPC) | Russian; Module 1 additionally in the language of each state of recognition |
These structures shape the procedures that sit on top of them. The FDA processes two application types: a New Drug Application (NDA) for a new drug and a Biologics License Application (BLA) for a biological product. The Agency requires substantial evidence of safety and efficacy, which in practice means at least two adequate, well-controlled clinical trials.
The EU offers a choice of pathways. The centralized procedure is mandatory for biotechnology-derived medicines, orphan drugs, and products for oncology, diabetes, HIV, and neurodegenerative disease. For other products, applicants choose between the decentralized procedure (DCP), where approval is sought simultaneously in several countries, and the mutual recognition procedure (MRP), where an approval already granted in one country is extended to others.
The EAEU follows a similar logic, with its own set of deadlines. Decision No. 78 sets out several pathways: mutual recognition, the decentralized procedure, and dossier alignment with Union requirements for medicines that were previously registered only nationally. A separate expedited assessment applies to orphan drugs, pediatric products, and medicines of exceptional public health significance.
Table 2. Registration timelines by procedure
| Procedure | First (reference) state | Second state or state of recognition |
|---|---|---|
| EAEU, mutual recognition | Up to 140 working days (para. 46, Decision No. 78) | Up to 60 working days after dossier access is granted (para. 68) |
| EAEU, decentralized procedure | Up to 140 working days | Up to 50 working days, running in parallel (para. 84) |
| EAEU, dossier alignment | Up to 70 working days (para. 173) | Follows the mutual recognition procedure |
| EAEU, expedited assessment | Up to 100 working days (para. 120.11) | Not applicable |
| EMA, centralized procedure | 210 days of active CHMP assessment | The Commission’s decision adds an administrative phase; actual market access takes 12–15 months |
| EMA, accelerated assessment | 150 days of active assessment | Not applicable |
| FDA, standard review | 10 months from submission of a complete dossier | Not applicable |
| FDA, priority review | 6 months from submission of a complete dossier | Not applicable |
The time an applicant takes to respond to a request for information is excluded from all of these clocks. The EAEU and the EMA both use a clock-stop mechanism, while the FDA counts its 10 and 6 months from the date a complete dossier is filed, not from the date of final approval.
Entry costs differ by an order of magnitude. In fiscal year 2025, the FDA fee for an application with clinical data was $4,310,002; effective 1 October 2025 (FY2026), it rose to $4,682,003, and the annual program fee rose from $403,889 to $442,213. In the EU, Regulation (EU) 2024/568 took effect on 1 January 2025, revising the EMA’s fee structure while keeping reductions for small and medium-sized companies. In the EAEU there is no single Union-wide fee: each member state sets its own registration and assessment fees.
Mutual recognition of inspections is gradually easing the burden on manufacturers. Effective 1 October 2025, an expanded Mutual Recognition Agreement (MRA) between the EU and the US lets the EMA rely on FDA inspections of manufacturing sites both inside and outside the United States. At the same time, since May 2025 the FDA has been expanding its use of unannounced inspections of foreign facilities, moving away from its earlier practice of giving advance notice to overseas manufacturers. In the EAEU, a valid Union GMP compliance document remains a mandatory condition for filing a dossier, and EEC Council Decision No. 34 of 22 May 2025, added a new ground for suspending an already-issued marketing authorization: if a manufacturing site is included in the inspection plan and has not undergone inspection within 3 years of the registration procedure being completed, the Union GMP compliance document is deemed absent.
Clinical data requirements are converging too, though at different speeds. The FDA accepts trials conducted outside the US if they meet GCP standards and the results can be extrapolated to the US population. The EMA more often requires European patients in pivotal trials and an agreed Pediatric Investigation Plan (PIP) before an adult formulation can be registered. In the EAEU, new Good Clinical Practice rules took effect on 9 March 2026, adopted by EEC Council Decision No. 63 of 1 August 2025, as a revised version of Decision No. 79 of 3 November 2016. The rules are built on the guideline of the International Council for Harmonisation (ICH), E6(R2), and add requirements for computerized system validation and data integrity.
Post-marketing surveillance follows a similar principle. How strictly it is enforced differs. All three systems have moved to periodic benefit-risk evaluation rather than relying only on adverse-event reports. In the EAEU these obligations are set out in EEC Council Decision No. 87 of 3 November 2016, «On Approval of the Good Pharmacovigilance Practice Rules of the Eurasian Economic Union.» In the US, the FDA’s Risk Evaluation and Mitigation Strategies (REMS) program can require mandatory physician training or restrict distribution channels for higher-risk products — something EU and EAEU risk management plans (RMPs) do not typically include.
Direct-to-consumer advertising of prescription drugs is allowed only in the US; in the EU and the EAEU it is banned, and all communication about a product goes through medical representatives and specialized publications.
The competition to be first to approve a breakthrough therapy is also structured differently in each system.
Table 3. FDA expedited pathways
| FDA | What it does |
|---|---|
| Fast Track | Frequent meetings with the Agency and rolling dossier submission |
| Breakthrough Therapy | Senior FDA leadership guidance based on preliminary clinical data |
| Accelerated Approval | Approval based on surrogate endpoints, with a commitment to confirm benefit after launch |
| RMAT | Status for cell and gene therapies, with Breakthrough Therapy incentives |
In the EU, a similar role is played by the PRIME scheme: an early CHMP rapporteur and detailed scientific advice during development. The EAEU has no separate multi-tier program; instead it has an expedited assessment for orphan, pediatric, and high-priority products (up to 100 working days) and a conditional marketing authorization for unmet medical need, where the full body of clinical data can follow after launch.
The use of real-world data (RWD) and the evidence built on it (RWE, real-world evidence) is converging across all three systems more slowly than inspections or fees, but the direction is the same. In the EAEU this is addressed by EEC Council Recommendation No. 1 of 18 October 2024, on common approaches to RWD/RWE regulation, and EEC Board Recommendation No. 15 of 10 June 2025, with guidance on using such data in registration. These are recommendations, not binding rules, for now. Applicants should treat real-world data as a supplement to the dossier rather than a substitute for standard trials — an approach consistent with FDA and EMA practice, where RWD more often strengthens post-marketing surveillance than replaces primary clinical trials.
What to do
Choose the reference state based on the type of product. For orphan and pediatric products in the EAEU, plan around the expedited assessment (100 working days); for everything else, plan around the standard 140-working-day timeline. In the US, weigh the benefit of priority review against how ready the dossier actually is for a 6-month cycle: a shorter deadline does not forgive an incomplete data package.
Build a modular dossier with room for three formats. The common CTD (Common Technical Document) core works for all three systems.
Module 1 will need to be adapted for each system separately:
for the EAEU, Russian-language documents and packaging mock-ups in the language of each state of recognition;
for the EU, the SmPC and patient information leaflet in the languages of every member state where authorization is sought;
for the FDA, Form 356h and the environmental assessment.
Check whether your facility falls within the expanded MRA scope. Since 1 October 2025, the EMA can rely on FDA inspections carried out outside the US. If the facility has already passed an FDA inspection, this can remove one of the planned EMA inspections and save months when preparing to enter the European market.
Tie the status of your EAEU national registrations to the 31 December 2025 deadline. If the alignment application was filed before that date, the registration remains valid for the review period: up to 3 years in the reference state and up to 2 years in each state of recognition. If no application was filed, but the product had been on the market for at least the last 3 calendar years as of 1 December 2025, circulation is allowed until 1 January 2027, under Russian Government Resolution No. 353 of 12 March 2022.
Update clinical trial procedures for the new EAEU GCP rules. The rules adopted under Decision No. 63 took effect on 9 March 2026, and require revisiting computerized system validation and data integrity practices, even for protocols already approved under the previous version.
Behind these differences runs a shared trend: toward mutual recognition of inspections, faster review cycles, and common ICH standards. The FDA, the EMA, and the EEC still protect their own markets through their own Module 1 requirements and local clinical data, so no single regulatory passport exists yet. A company that plans three parallel tracks instead of filing one market at a time saves months on every launch.
Regulatory framework:
1. EEC Council Decision No. 78 of 3 November 2016, «On the Rules for Registration and Examination of Medicinal Products for Human Use» (as amended 26 November 2025)
2. EEC Council Decision No. 34 of 22 May 2025, «On Amendments to Decision No. 78»
3. EEC Council Decision No. 79 of 3 November 2016, «On Approval of the Good Clinical Practice Rules of the Eurasian Economic Union» (as amended 1 August 2025)
4. EEC Council Decision No. 63 of 1 August 2025, «On Amendments to the Good Clinical Practice Rules of the Eurasian Economic Union»
5. EEC Council Decision No. 87 of 3 November 2016, «On Approval of the Good Pharmacovigilance Practice Rules of the Eurasian Economic Union»
6. EEC Council Recommendation No. 1 of 18 October 2024, «On Common Approaches to Regulation of RWD/RWE»
7. EEC Board Recommendation No. 15 of 10 June 2025, «On Guidance for the Use of RWD in Drug Registration»
8. Resolution of the Government of the Russian Federation No. 353 of 12 March 2022
9. Federal Food, Drug, and Cosmetic Act; Prescription Drug User Fee Amendments (PDUFA VII); Federal Register notices 2025-14413, 2024-16875
10. Regulation (EU) 2024/568 on fees and charges payable to the European Medicines Agency
11. Regulation (EC) No 726/2004; Directive 2001/83/EC
12. Mutual Recognition Agreement between the EU and the US, Sectoral Annex on Pharmaceutical GMP (as updated 1 October 2025)