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Drug registration in Russia

Contact Regapharm for drug registration in Russia - the best way to meet your challenges


The drug registration procedure in Russia is set forth in accordance with Federal Law 61 On Circulation of Medicines as amended on July 3, 2016 (effective from January 1, 2017).
The Ministry of Healthcare (Minzdrav) regulates the drug registration procedure in Russia. Click here to view the State Drug Register (as of January 26, 2017).

Duration of the drug registration process in Russia:

  1. 160 business days or less, not including the time needed for answering questions from experts (90 business days).
  2. 80 business days (for orphan drugs, generics, and medicines specifically for children under the age of 18).

Please note that the actual registration period takes about 12 months, as the above timelines exclude periods for submitting samples and standards, and for responding to Minzdrav’s requests. Note that clinical test periods will be specific for each drug.

Dossiers required for drug registration in Russia are provided in the form of general technical documents similar to CTD.

Amendments to Federal Law 61 require that drug registration dossiers include Russia’s GMP Certificate (Good Manufacturing Practice, an international standard containing the production rules, standards and instructions). Drug manufacturers will need to obtain compliance certificates with the GMP rules issued by the Ministry of Industry and Trade of the Russian Federation.

These certificates are issued for each specific registration dossier for every form of the drug, so it is possible to file only one drug with different quantity, dosage and concentrations at a time.

Pharmacovigilance reports have to be filed with Roszdravnadzor once every six months within the first two years of drug registration in Russia. Eventually, it will be submitted once a year during the following three years and once every five years afterwards.

Drug registration in Russia requires the availability of the document list by document type, i.e. administrative, chemical, pharmaceutical, biological, pharmacological, toxicological and clinical types of documents (Clause 1 added on July 1, 2015 by Federal Law 429-FZ dated December 22, 2014).

The clinical risk and benefit analysis is an integral step of drug registration in Russia.

The State duty for drug registration in Russia is RUB 330,000, including RUB 325,000 for analysis and RUB 5,000 for issuing a registration certificate (Clause 1 added on July 1, 2015 by Federal Law 429-FZ dated December 22, 2014).

For more details about the changes in some of the regulations of the Russian Federation as of July 3, 2016 (as amended on July 4, 2016) click here.
Regapharm will help you with the registration of any type of drug, whether they are generics, originators or biosimilars. We pursue the whole process, from concept to registration certificate, in strict compliance with the scheduled deadline.

Get the most out of our services provided by our reliable and goal-oriented expert team.

We are always available to support your efforts in tapping your drugs into the Russian market. For more details about drug registration in Russia please use the form provided below. Do not hesitate to contact us by e-mail.


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