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Registration of pharmaceutical products in Russia

Register medicinal products and pharmaceutical substances with “Regapharm”!

Be the master of your time.  

Our knowledge - your result!

Working with us - what are your benefits?

We guarantee that qualitative, effective and safe national or imported production will enter into the State Register of pharmaceutical products!  Each stage of registration has its regulated duration. If your Registration dossier doesn’t comply with the requirements, or even one document from the package is incorrect, you will be refused. You will return to the first stage regardless of which registration stages you have already passed. This means loss of main business resources - time and money.

We guarantee that you pass all stages without any problems. With our registration support failure is minimized.


The State Register of Medicinal Remedies

The State Register of Medicinal Remedies is the list of national or imported drugs, preventive medicine and diagnostic agents, registered by the Ministry of Health of the Russian Federation.
We will help you to include your product in the State Register of Medicinal Remedies, to conduct Clinical Trials and we provide other cost and time effective services.
Save resources for your business - register your product using Regapharm’s services.


Registration of medicinal products and pharmaceutical substances

The registration of medicinal products and pharmaceutical substances in Russia is complex work. Documents are prepared in accordance with special requirements. The special requirements are regularly renewed. Only our initiative and close cooperation with regulatory authorities allows us to quickly adapt to new conditions and to achieve a result in spite of any changes!
Regapharm works with Russian and foreign pharmaceutical companies. We help you register medicine optimally with minimum cost and the best strategy. We minimize first registration failure.


We offer registration services:

  1. Drugs
  2. Pharmaceutical substances.


How we do our work

  • One-and-done - we will register medicine in one attempt and without any bureaucratic barriers.
  • We check documentation just as the MoH experts do.
  • We generate the best registration strategy for your product. We show you how to do the product registration quickly and effectively.
  • We conduct negotiations with the regulatory authorities. We enter into contractual relationships between all parties of the registration process.
  • We perform an expert pharmaceutical examination.
  • We provide complex follow-up support in order to obtain your registration certificate.
  • We prepare your Summary of Product Characteristics.
  • We prepare your Product specification file in accordance with the latest regulations.


What we do more

  • We consult our clients regarding specific particularities of the drug registration procedure.
  • We prepare the registration plan and the list of the required documents.
  • We adapt foreign partner documents to RF legislation requirements.
  • We prepare the package design.
  • We provide complex support of the registration procedure.
  • We obtain the authorisations, resolutions and official requests from the federal agency authorized for official drug registration.
  • We prepare accessory materials, requested by the federal agency authorized for official drug registration.
  • We obtain your Marketing Authorization and documentation approval (Product specification file, patient information leaflet, drug package design).


Company “Regapharm” organize and conduct

  • Preclinical and Clinical Studies.
  • Bioequivalence study.
  • Comparative study of antibacterial effect of antibiotics.
  • Comparative analysis of the dissolution kinetics.
  • Any other Clinical studies.


Registration process

  1. If necessary at the dossier examination stage, the preclinical and clinical studies are conducted before the registration procedure. When the preclinical study is completed the applicant submits the documents for Market Authorizations according to FL-61.2. Then permission for the conduct of a clinical study in the Russian Federation is obtained.
  2. After completion of the clinical study for drug quality is performed, the evaluation of the expected benefit to possible risk ratio is done.
  3. The Ministry of Health of the Russian Federation makes a decision on the drug’s registration and its inclusion into the State Register of Medicinal Remedies. The Ministry of Health of the Russian Federation issues the Marketing Authorization.


The advantage of working with us

  • Only excellent quality services from drug registration to the legal implementation of the drug inside the Russian Federation.
  • Quality assurance of the consulting services.
  • Complex support of the drug’s marketing project for future promotion.
  • Good history of successful drug registrations.


Drug registration is required for marketing within the Russian Federation. This is the state examination of drug quality, efficiency and safety, which gives approval for the medicinal use of the drug.
Law No.61-FL “On the circulation of medicines” was introduced in 2010, came into effect on September 01, 2010. The drug registration procedure has since been renewed.
There are 4 law revisions: № 192-FL on July, 27 2010, № 271-FL on October, 11 2010, № 313-FL on November, 29 2010, № 409-FL on December, 06 2011.


Laws and regulations, controlling the drug and pharmaceutical substances registration procedure

  • The Federal Law  № 61-FL “On the circulation of medicines” on April, 12 2010 (came into effect on September 01, 2010).
  • Decree of the Ministry of Health and Social Development of the Russian Federation on November, 23 2011. N 1413н “On confirmation of methodological recommendations for the contents and formatting of the required documents for dossier registration in order to receive official drug registration”.

Drugs which require registration in Russia

  1. Medical products, which requires a compulsory license.
  2. In-house design drugs.
  3. Previously registered drugs with future dosing changes.
  4. Newly mixed medicine products, previously registered


Drugs which doesn’t require compulsory registration

  1. If the drugs are made by prescription or released by the holder of manufacturing authorisation and meet the requirements of medical centers.
  2. If the drugs are developed for oncological disease treatment and are prepared by medical center by itself.
  3. If the drugs are exported individually for private use only.


The registered drugs of one manufacturer cannot have:

  1. A different name if the formulation is the same.
  2. The same name if the formulations are different.


Duration of the drug registration period
160 working days for original and generic drugs.
Time for Clinical study conduct is not included.


“Regafarm” will solve all non-typical problems according to client requirements.

We prefer long-term working relationships with our clients. We will find optimal solutions for each problem! We will help you to include your product in the State Register of Medicinal Remedies, conduct the Clinical Trial and we offer many other services.

We are always available! Phone us or send an e-mail!

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