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Registration of Active Pharmaceutical Indredients (API) in Russia

API registration procedure and timeline

The procedure of API enrollment to the State Register of Medicines comprises the following stages:


Pharegis activities

Typical duration by Pharegis


Gap analysis and review of CMC (chemical, analytical, manufacturing) and administrative dossier parts,

3-5 business days


Considering the dossier updates with Customer,

receipt of additional and adjusted dossier parts

5-10 business days (depends on:

 customer procedures)


·   Local notary legalization of required administrative documents.

·   Preparation of the ND draft;

·   Translation of all dossier parts to Russian (required);

·   Preparation of the application (physical and electronic);

·   Providing calculation for required quantities of samples and reference standards for the official QC expertise;

·   Paying state duty to MoH.

10-20 business days

(depends on:

 API type, dossier complexity)


·   Submission of the API registration dossier to Russian MoH;

·   Submission for official permissions for import of the samples and reference standards;

·   Receipt of official MoH permission letters for import of the samples and reference standards.

5-7 business days


·   Initial dossier review by MoH; MoH decision for the expertise

·   Import and customs clearance of the samples and reference standards

·   Submission of the samples and reference standards to FSBI SCEEMP for the official QC expertise

15-30 business days (depends on:

MoH, shipment readiness,

queue of applicants)


Receipt of the official expertise request

20-55 business days

(depends on the expertise)


Official addressing the official expertise request

10-20 business days

(depends on customer)


Obtaining API registration

15-25 days

(depends on:


Total expected term is 4-8 months while having only single official MoH request (that is what we focus on at preparatory stages 1-3 and it is the best option available) as well as submission of RP DMF by Pharegis together with AP DMF within single initial submission.

This timeline range is practically attainable in case of full cooperation from the customer side – in terms of shipment of the samples and addressing specific points of the official request (e.g. provision of additionally requested documents). 

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