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  • 18/07/2019: Pharegis implemented optimized procedures for state registration of pharmaceuticals in Eurasian Economic Union.
  • 20/06/2019: Pharegis updated timelines and practical approaches for Russian and EEU GMP inspection applications and procedures.
  • 03/04/2019:  Renewed general monographs of Russian state pharmacopeia XIV ed. have been analyzed.

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Russian Regulatory News

Preclinical studies for biopharma products (original biopharmaceuticals, biosimilars, vaccines, monoclonal antibodies, immunoglobulins, biopharmaceutical orphane drugs) by regulatory CRO Pharegis in Russia

Registration of biopharmaceutical drugs in Russia

assumes quite complex set of activities. Due to strict and spedific regulatory requirements in Russia to biopharmaceuticals e.g. biosimilar products, in particular, completed preclinical studies program that is needed in frames of registration dossier for a biopharmaceutical product can be much more sophisticated and challenging than set of standard tests for an original “traditional” pharmaceutical.

Depending of type and clinical pharmacology class of biopharma product its preclinical programs should have following studies:

  1. Pharmacodynamics - in vitro and/or in vivo
  2. Pharmacokinetics - in vitro and/or in vivo
  3. Immunogenicity
  4. Immunotoxicity
  5. Safety pharmacology for key systems of organs
  6. Reproductive toxicity
  7. Cancerogenicity
  8. Mutagenicity
  9. Drug interaction safety
  10. Other specific studies

Specific preclinical program is required for registration of new vaccines in Russia.

For biotechnological medicines like monoclonal antibodies, recombinant protein-based pharmaceuticals and other product produced by cell lines, it is needed to present quality confirming documents for every stage of cell bank growth and purification as well as every source material used in biotechnological manufacturing.

 

Our experts have comprehensive experience in managing and conduction of preclinical studies programs for biopharmaceuticals in various GLP-compliant centers all over Russian Federation. Also we can analyze your existing preclinical studies portfolio, advising best way to handle specific studies missing for registration in Russia.

We provide fast and free calculation of your preclinical program budget and timeline. Send us your request or simply call us and our experts will discuss every detail of your project with you and you will receive working solution that will bring you Clear Regulatory Answers for your business.

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News and press releases

  • EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US, , 16/08/2019
  • EMA closed 15 August 2019 , , 13/08/2019
  • Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies): workshop report published , , 31/07/2019
  • Names of liposomal medicines to be changed to avoid medication errors, , 31/07/2019