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Service registration of pharmaceutical products (PP)

What we can do for the successful organisation and support of drug registration proceedings:
  • The registration of generics and medical products in Russia.
  • The registration of variations and changes to the dossier.
  • The formation of the document packages required for obtaining the permission to conduct clinical trials and drug research.
  • The organisation and conduct of pre-clinical studies on the medicinal product.
  • The organisation and conduct of clinical studies on the medicinal product for its registration within the territory of the Russian Federation.
  • The registration of drugs.
  • Pharmacovigilance. The preparation and submission of Periodic Drug Safety Reports.
  • Carrying out any repeated registration procedure for the medicinal product.

"Regapharm" offers you a comprehensive approach and effective solution of the problem of registration of medicinal products

The registration procedure is described in accordance with the Federal Law No. 61 "On the Circulation of Pharmaceuticals" with all amendments including those entered into force on January 1, 2016

Pre-expertise of the dossier

  • Initial examination of the dossier, the customer consultation
  • Identifying the need for pre-clinical (DKI) and clinical (CT) studies in accordance with the Federal Law of 12.04.2010 number 61-FZ "On the Circulation of Medicines" as amended on 29/12/2015
  • Evaluation of the completeness of the submitted materials and their compliance with the requirements of registration authorities
  • Calculating the cost of registration, coordination with the customer

Pre-clinical studies of a drug – in the case of need, the determination of step I.

  • Selection of scientific centers for pre-clinical drug trials
  • Preparing the design if pre-clinical drug study
  • Execution of pre-clinical trial
  • Preparing Statistical report of trial and Final Pre-clinical study report
Presentation to Ministry of Health results of high quality pre-clinical studies, which were correctly designed and executed is an essential tool for obtaining permission to conduct a Clinical Study.

Conducting the Clinical Study of the drug - if necessary, determined in step I.

  • Development and approval of the package of documents required to obtain permission to conduct the Clinical Study, selection of clinical sites
  • Obtaining permission for Clinical Study
  • Conduct of Clinical Study, processing of statistical data, preparation of the report, the Ministry of Health notification on the completion of the Clinical Study
  • Examination of the expected benefits and possible risk ratio of the use of the drug by the authorized body (FGBU NC ESMP)

Submission of the dossier of a medicinal product to the Ministry of Health

  • Compilation and completion of the dossier in accordance with Federal Law - 61
  • Registration on the Ministry of Health website, the formation of the electronic application
  • Submission of the dossier to the Ministry of Health

Examination of the quality of the drug and the examination of the relationship of the expected benefits and possible risks of the use of the drug for medicinal use

Conducted by the State authorized body (FGBU NC ESMP)

Completion of the registration process, introduction of the state register

  • Obtaining Registration Certificates and delivering them to the Customer
List of documents required for registration of pharmaceutical products
List of documents required for obtaining Russian GMP certificate by a foreign producer
Federal Law от 12.04.2010 № 61-ФЗ «Drug circulation»

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