Pharmaceutical /Medicine/Drug/OTC registration in Russia

MOH – Russian Ministry of Health  

MOH Website- https://minzdrav.gov.ru/en

Regulatory Authority- Minzdrav

Local Authorized Representative Required –Yes

Russia is a member of the Eurasian Economic Union and thus, issues associated with the state registration of medicinal products in Russia are regulated by the Decision of the Council of the Eurasian Economic Commission.

Drug Registration in Eurasian Economic Union

• Mutual Recognition

A Market Authorization Holder (MAH) is a crucial component in streamlining the medication registration procedure in the dynamic and quickly changing pharmaceutical market of the European Union (EAEU). An individual or a business can take on this position; they are not required to be citizens of an EAEU member state. In essence, the MAH is in charge of guaranteeing the efficacy and safety of the medications they manufacture or supply throughout the union.

In the EAEU, the mutual recognition mechanism provides a quick and easy way to get drug approval. The registration dossier and other required documents are sent to the Competent Authority (CA) after the Market Authorization Holder (MAH) chooses a reference state.

In about two weeks, the CA reviews the records in order to determine whether to move forward with a full investigation. This comprehensive examination examines the trial results in conjunction with the medical product’s quality, safety, and efficacy. The authorities have the right to examine medicine samples for quality and do an ad hoc examination of production sites if they think it is required.

After the roughly six-month-long evaluation process, the CA drafts an expert report and decides whether to approve or deny the Market Authorization Application (MAA) for the medicine. An additional two weeks are spent in this decision-making process. The procedure can take up to 210 calendar days in total, though it may be extended if the CA asks for more details.

A five-year registration certificate is provided following market approval. Every EAEU member state uses the same model for this certificate. The validity of the certificate usually lasts forever upon re-registration.

• Decentralized Procedure

Within the European Union, a different route to market authorization is provided by the decentralized medication registration process. This approach entails simultaneously submitting an MAA to multiple EAEU members, if not all of them.

In this process, most administrative procedures are handled by one member state, designated as the reference. This reference state is frequently selected according to criteria like its market size, regulatory ability, or significance to the drug’s therapeutic area.

The evaluation is carried out by the reference state, and the other states to which the application has been submitted are informed of its results. The marketing permission is granted by the reference state and confirmed by all participating states if no objections are raised by the other states.

When a business wants to simultaneously introduce a product into several EAEU nations, it frequently takes this route. Getting extensive market authorization through this method can be quicker and more effective than applying separately for each state.

By streamlining the EAEU’s drug registration system, both of these measures hope to facilitate MAHs’ efforts to introduce safe and effective medications onto the market. Any pharmaceutical business or individual wishing to navigate the drug registration landscape in the European Union must have a thorough understanding of these channels.

Drug Approval Process

1.Application for Drug Registration –The Application for the Drug Registration is done in the eCTD format.

2.Review by Department for State Regulation of Drugs Circulation (MoH)-The Drug Division of the Russia reviews the application for the new drug registration.

3.Expert Review: Conducts a thorough expert review of the registration application. A team of experts assesses the data to ensure that the drug is safe, effective, and of high quality.

4.Decision of Approval: Mindrav decides whether to license the medication for sale in Russia based on the findings of the expert review. A marketing authorization is given to the medication if it is accepted.

5.After-Market Monitoring: Post-approval surveillance is carried out to keep an eye on the medication’s effectiveness and safety in real-world settings. This aids in locating any uncommon or persistent negative effects that might not have shown up during clinical studies.