If you are interested in marketing your medicinal product in the fast-growing pharmaceutical market of the Eurasian Economic Union (EAEU) and if you want to how to apply for market authorization in the EAEU, this blog post is for you. The first part of this article describes why the EAEU is an exciting market for drug registration and outlines the two different pathways for drug registration in the Eurasian Economic Union (EAEU). Additionally, it shares insight into aligning the dossiers of previously registered drugs with the new requirements.
The Eurasian Economic Union
The EAEU consists of Russia, Kazakhstan, Belarus, Armenia, and Kyrgyzstan and has a combined population of more than 185 million people. The GDP is estimated at around $5 trillion, with a fast-growing pharmaceutical market. For Russia, the expected turnover for 2021 is around $39 billion, which is up from $28 billion in 2017.
The EAEU was formed in 2014 and is headed by the Eurasian Economic Commission (EEC). In recent years, the EAEU has taken steps to unify the pharmaceutical market. This includes the creation of common drug registration procedures, and in the future might include a single pharmaceutical regulator similar to the European Medicines Agency (EMA). The EEC has introduced the ‘Agreement on common principles and rules of circulation of medicines within the Eurasian Economic Union’ at the end of 2014, and the ‘Rules of registration and expertise of medicinal products for human use’ (EEC Decision No. 78) on November 3rd, 2016. The decision describes two pathways of registering drugs in the EAEU, which have become the official procedures at the start of 2021. Drugs registered before December 31st, 2020, need to comply with the EAEU requirements by the end of 2025.
Pathways For Drug Registration In The Eurasian Economic Union (EAEU)
As in other pharmaceutical markets, in the EAEU, a Market Authorization Holder (MAH) performs the drug registration and can be a person or company without residing in an EAEU member state.
In the EAEU, you can request market authorization in two ways:
1. The mutual recognition procedure for drug registration in the Eurasian Economic Union (EAEU)
Here you file a Market Authorization Application (MAA) in a member state of choice, and aftermarket approval, you apply for recognition of the approval decision in the other states.
2. The decentralized procedure for drug registration in the Eurasian Economic Union (EAEU)
Here you file an MAA in all (or several) EAEU states simultaneously and choose one member state as a reference to deal with the majority of administrative procedures.
Common Technical Document Format In The Eurasian Economic Union (EAEU)
For the MAA, an electronic Common Technical Document (eCTD) format is used that resembles the ICH CTD format.
The EAEU CTD consists of five modules:
- Administrative information
- Summary of the Common Technical Document
- Reports of pre-clinical studies
- Clinical trial reports
Special requirements may apply for specific medicinal product types, such as generic drugs, vaccines, or Advances Therapy Medicinal Products (ATMPs). Some modules and sections of the CTD are allowed to be submitted in English. Modules 1 and 2 must be submitted in the local language, except for the GMP site inspection reports, the pharmacovigilance system master file (PSMF), and the risk management plan (RMP). For the PSMF and the RMP, local language summaries are required. Modules 4 and 5 can be submitted in English entirely and large parts of Module 3, with a list of sections of Module 3.2 that need to be submitted in the local language.
Appendices 4 and 5 of EEC Decision No. 78 lists all requirements of the eCTD.
Mutual Recognition Procedure For Drug Registration In The Eurasian Economic Union (EAEU)
The MAH first selects a reference state in the mutual recognition procedure and submits the registration dossier and necessary documents to the competent authority (CA) there. The CA makes a preliminary assessment of the documents within approximately two weeks and decides whether to proceed with a complete examination. Subsequent evaluations include reviewing the safety, efficacy, and quality of the medicinal product and the trial data. Additionally, the authorities can conduct an (unscheduled) inspection of manufacturing sites and test drug samples for quality. This process takes approximately six months. Finally, the CA prepares an expert report and decides on drug registration (or rejection of the MAA) within a further approximate two weeks. The overall process has a maximum duration of 210 calendar days, with an extension possible if a CA requests additional information.
Aftermarket authorization in the reference state, the MAH provides access to the eCTD and the expert report in the EAEU unified register for the other member states. Module 1, the Normative Document (ND), the Summary of Product Characteristics (SmPC), labeling, and instructions of use have to be submitted in local languages of the individual member states. CAs from the other member states are then allowed to request further information for 50 days after gaining access to the documentation. If potential requests are answered adequately, the individual member states grant market authorization. If a member state declines to recognize the market approval of another member state, the disagreement is settled by the Expert Committee on Medicines of the EEC. The recognition process has a maximum duration of 90 calendar days, making the maximum duration of the whole mutual recognition procedure 300 calendar days.
Aftermarket approval, a registration certificate is issued with a validity of five years. This certificate has a uniform model for each EAEU member state. When re-registration is applied, the certificate validity is usually without an expiration date.
Decentralized Procedure For Drug Registration In The Eurasian Economic Union (EAEU)
The decentralized procedure is very similar to the mutual recognition procedure, but the approval process by each member state takes place in parallel. The MAH still selects a reference country that will handle the most significant part of the approval process. Module 1, the ND, SmPC, labels, and other relevant documentation have to be submitted in local languages to each CA of the respective member states. The decentralized procedure has a maximum duration of 210 calendar days and is thus faster than the mutual recognition pathway.
Procedure For Previously Approved Drugs In The EAEU
Medicinal products that have received market authorization before December 31st, 2020, are required to comply with the new EAEU standards by December 31st, 2025. MAHs largely follow the mutual recognition procedure: they select a reference state to submit the eCTD and other documents to, harmonized with the new regulations. It is important to note that this harmonization process should not include new information on safety, efficacy, or technical details of the medicinal product; i.e., any variations should first be submitted and processed for the old eCTD. The reference state performs the evaluation and potential inspections and then provides an expert opinion. The other states follow the recognition procedure based on this opinion and the eCTD.
The procedure for bringing a medicinal product in compliance with the new requirements is accelerated and has a maximum duration of 100 calendar days. If the drug was already registered in at least three member states for five years or more, a registration certificate without an expiration date would be issued. In other cases, the authorities grant the standard validity period of five years.
Dossier Maintenance And Re-registration
Aftermarket approval, it is vital to maintain the registration dossier and submit variations to the appropriate CAs. The registration certificate, which among other information, contains the SmPC and labeling, also has to be updated in case variations are submitted. Furthermore, a maximum of 210 days before the expiry of a registration certificate, a re-registration request can be submitted, after which a certificate without an expiration date can be obtained.
Considerations When Registering A Drug In The Eurasian Economic Union (EAEU)
The EAEU pharmaceutical market is an appealing and growing market for medicinal products. Since the start of 2021, the procedure for drug registration in the member states has been unified, and approval for an MAA now has a maximum duration between 210 and 300 days for all EAEU member states. For previously registered drugs, documentation has to be harmonized with the new regulation by December 31st, 2025, for which an accelerated approval procedure with a maximum duration of 100 days exists.
Suppose you are considering bringing your medicinal product to the EAEU market. In that case, you should consult with experts who have extensive knowledge of EAEU regulation and local language knowledge (usually Russian). Knowing the differences in working methods of the national CAs can help you select the best country as a reference for the drug registration process, thereby accelerating and simplifying the approval process.
Successfully transition to EAEU marketing authorization
All national medicinal product MAs need to be revalidated per EAEU guidelines by the end of 2025. But how to develop a successful submission strategy?
Join the webinar and find out how to:
1. What are the main points you need to consider when going into the upgrade procedure?
2. What do you need to know about EAEU GMP certification?
3. What are the readability user testing requirements?
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