Development vector of regulatoryprocedures of biological medicinesin RussiaElena MaksimkinaHead of Department of state reg...
Development of formal institutes in thefield of Health care in RussiaNational project “Health”Federal Law FZ-323 of 21.11....
Main areas of regulation3Modifications de la loifédérale « sur ladistribution desmédicaments »Développement du cadreconcep...
Need to Define the Regulation Object62) Biological medicinal product is a medicinal product, the active substance of which...
Need to Define the Regulation Object71) Biotechnological medicinal product - a medicinal product that is manufactured thro...
Need to Define the Regulation Object122) Biosimilar medicinal product (biosimilar) – a biological medicinal product that i...
Treatment Process Drivers•State•Physician•Pharmacist•Manufacturer –(in particular, via theinstitute of medicalrepresentati...
Reasons to Discuss Intercheangibility1. Economic aspect Medicinal treatment cost increase: Savings on purchases Afforda...
Biological Medicinal Products Registered inthe Russian Federation9Group Number of SKUs (in particular,taking into account ...
FSBI «SCIENTIFIC CENTRE FOR EXPERTEVALUATION OF MEDICINAL PRODUCTS»OF THE MINISTRY OF HEALTHThe Scientific centre’s divisi...
For purposes of implementing the new state policyregarding the circulation of medicinal products(Federal law № 61-FZ, date...
Organizational structureSCIENTIFIC CENTRE FOR EXPERTEVALUATION OF MEDICINAL PRODUCTSADMINISTRATIVE ANDMANAGERIAL DIVISIONS...
Main functions of the FSBI “SCEMP” assessment of applications for the registration of medicinal products inRussia and pos...
CENTRE OF PHARMACOPOEIA AND INTERNATIONALCOOPERATION Preparation of the first State Pharmacopoeia in the contemporary his...
Greatness is not inwhere we stand,but in whatdirection we aremovingOliver Wendell Holmes
Thank you for your attention
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32. Development vector of regulatory procedures of biological medicines in Russia

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Provides an overview of the development of biotherapeutic & biosimilar regulations in Russia.

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32. Development vector of regulatory procedures of biological medicines in Russia

  1. 1. Development vector of regulatoryprocedures of biological medicinesin RussiaElena MaksimkinaHead of Department of state regulation of medicine, Ministryof HealthPh.D. (pharmacy)Moscow 15.05.2013BIOTHERAPEUTIC MEDICINES
  2. 2. Development of formal institutes in thefield of Health care in RussiaNational project “Health”Federal Law FZ-323 of 21.11.2011 “ On Fundamentals ofHealthcare Protection of Citizens in the Russian Federation”.Federal Law FZ-61 of 12.04.2010 “On the Circulation ofPharmaceuticals”Strategy of the development of pharmaceutical industry until2020Concept of health care development until 2020Programs of modernizing health care of the RussianFederation
  3. 3. Main areas of regulation3Modifications de la loifédérale « sur ladistribution desmédicaments »Développement du cadreconceptuel :• médicaments biologiques• médicaments bioanalogiques• médicaments de référence• médicaments génériquesCréation des conditions pour un meilleurcontrôle officiel des prix des médicamentsHabilitation complémentaire du Ministère de la santé de Russie• validation de la liste des noms de médicaments• introduction d’un registre d’instructions concernant l’utilisation médicaledes médicaments• validation de règles pour un choix rationnel des noms des médicaments àusage médicalDéfinition desparticularités de lexamende certains groupes demédicamentsIntroduction de la notion de« médicaments orphelins » etde leur procédured’homologationHarmonisation avec la législationinternationale :• élaboration du dossier d’homologation• introduction des normes de pratiqueconforme clinique et pré-clinique
  4. 4. Need to Define the Regulation Object62) Biological medicinal product is a medicinal product, the active substance of which is apharmaceutical substance obtained or extracted from a biological source, and determination ofproperties and quality of which takes a combination of biological and physical/ chemicalmethods. Biological medicinal products include immune biological medicinal products, medicinalproducts derived from human and animal blood and plasma, biotechnological medicinalproducts, gene therapy and somatic cell therapy medicinal products;4The proposed wording takes into account the problems with the maximum assessment of thisgroup of medicinal products and includes the necessary groups of medicinal products and methods,so that to avoid including herbal medicinal products, glucose, antibiotics into the group of biologicalmedicinal products and other possible collisions.Classification of the variety of biological medicinal products by different classification attributes(production technology, source of medicinal product) is a strong aspect of the proposed definition.
  5. 5. Need to Define the Regulation Object71) Biotechnological medicinal product - a medicinal product that is manufactured through thestages using biotechnological processes, including recombinant DNA technology, the technologyof controlled expression of genes coding biologically active proteins in procaryotes andeucaryotes, including modified mammal cells, hybrydoma antibody and monoclonal antibodytechnology;72) Gene therapy medicinal product – a biological medicinal product, the pharmaceutical substanceof which represents or includes a recombinant nucleic acid that enables to regulate, repair,replace, add or delete some genetic sequence;73) Somatic cell therapy medicinal product – a biological medicinal product that represents orincludes cells or tissues with the biological features and physiological functions or structuremodified for the intended use, or that represents or includes cells or tissues not intended forperformance of the same basic functions in the recipient as in the donor5
  6. 6. Need to Define the Regulation Object122) Biosimilar medicinal product (biosimilar) – a biological medicinal product that is similar to theoriginator biological medicinal product in the same dosage form by quality, efficacy and safety;121) Comparator (reference) medicinal product – a medicinal product registered based on own pre-clinical and clinical trial data and used to assess quality, efficacy and safety of a genericmedicinal product, if there is no originator medicinal product corresponding to it in the StateRegister of Medicinal Products;123) Interchangeable medicinal product – a medicinal product, other than a biological medicinalproduct, with proven therapeutic equivalence to the originator medicinal product or thecomparator medicinal product, which is used for the same indications (except for theindications, which are protected in the Russian Federation by applicable patents), has the samequalitative and quantitative composition of active substances as well as the same dosage form,dosing rate and method of administration, and manufactured in accordance with the rules formanufacturing of and quality control over medicinal products;6
  7. 7. Treatment Process Drivers•State•Physician•Pharmacist•Manufacturer –(in particular, via theinstitute of medicalrepresentatives)
  8. 8. Reasons to Discuss Intercheangibility1. Economic aspect Medicinal treatment cost increase: Savings on purchases Affordability Competition between originator and generic medicinal products Market share Identity in terms of: Efficacy and safety Quality Consumer properties (convenience of administration, action spectrum)2. Therapeutic aspect8
  9. 9. Biological Medicinal Products Registered inthe Russian Federation9Group Number of SKUs (in particular,taking into account theproduction site)ForeignErythropoetins 20 8Interferons 53 20Monoclonal antibodies 42 37Insulins 61 40Somatropins 11 7G-CSF 24 17Heparins 55 25Plasma coagulation factors 31 19r-coagulation factors 9 3
  10. 10. FSBI «SCIENTIFIC CENTRE FOR EXPERTEVALUATION OF MEDICINAL PRODUCTS»OF THE MINISTRY OF HEALTHThe Scientific centre’s divisions on the map ofMoscow10
  11. 11. For purposes of implementing the new state policyregarding the circulation of medicinal products(Federal law № 61-FZ, dated 12 May, 2010)The institution’s legal organizational form and structure were changedNew functions and tasks were determinedState certification of experts was carried outScientific and methodological support for evaluation of quality, efficacyand safety of medicinal products is constantly being improvedFSBI «SCIENTIFIC CENTRE FOR EXPERTEVALUATION OF MEDICINAL PRODUCTS»OF THE MINISTRY OF HEALTH11FSBI «SCIENTIFIC CENTRE FOR EXPERTEVALUATION OF MEDICINAL PRODUCTS»OF THE MINISTRY OF HEALTH
  12. 12. Organizational structureSCIENTIFIC CENTRE FOR EXPERTEVALUATION OF MEDICINAL PRODUCTSADMINISTRATIVE ANDMANAGERIAL DIVISIONSQualityassurancedepartmentSCIENTIFIC DIVISIONSCentre for evaluation ofmedicinal products safetyCentre of pharmacopoeiaand internationalcooperationCentre of clinicalpharmacologyCentre of educationalprogramsCentre for planning andcoordination of researchand development activitiesEXPERT DIVISIONSCENTRE OF FPPEXPERTISE(5 boards)TESTING CENTREFOR EVALUATIONOF MEDICINALPRODUCTSQUALITY(11 laboratories)CENTRE OF MIBPEXPERTISE(3 boards)TESTING CENTREFOR EVALUATIONOF MIBP QUALITY(10 laboratories)MIBP CERTIFICATIONCENTREManagement andorganizationdepartmentReference information:Staff numbers of the Institution – 900 employeesMembers of the Russian Academy of Medical Sciences – 4Professors – 19Doctors of Science – 56Candidates of Science – 21412
  13. 13. Main functions of the FSBI “SCEMP” assessment of applications for the registration of medicinal products inRussia and post-authorization variations filling of already registeredmedicinal products in respect of their quality, efficacy and safety; evaluation of the pre-clinical trials results and assessment of the possibilityof carrying out clinical trials of medicinal products on the territory ofRussia, including international multicentre clinical trials; laboratory evaluation (testing) of medicinal products quality as part of theirregistration; carrying out scientific research, working out guidance documents related toquality, efficacy and safety of medicinal products, drawing uppharmacopoeial monographs for the state pharmacopoeia, organization oftraining workshops13FSBI «SCIENTIFIC CENTRE FOR EXPERTEVALUATION OF MEDICINAL PRODUCTS»OF THE MINISTRY OF HEALTH
  14. 14. CENTRE OF PHARMACOPOEIA AND INTERNATIONALCOOPERATION Preparation of the first State Pharmacopoeia in the contemporary history of Russia (SPhXII) – 5 parts2008 - I part SPh XII2011 - II part SPh XII – description of physical, physical-chemical and chemical methods ofanalysis, pharmacotechnological tests2012 - III part SPh XII – General pharmacopoeia monographs for immunobiological productsand methods of analysis, general requirements for dosage forms and medical products2013 - IV part SPh XII – herbs and herbal medicinal products2013-2014 - V part SPh XII – homeopathic medicines and methods of their analysis Participation in the work of the European Pharmacopoeia Commission aimed atinternational harmonization of quality standards of domestic medicinal productsReference. The Russian Federation has a status of the Observer State in the EuropeanPharmacopoeia Commission Elaboration of programs for harmonization of Russian national standards with normativedocuments of the EU countries, the USA, and the CIS countries in the sphere of medicinalproducts evaluation14FSBI «SCIENTIFIC CENTRE FOR EXPERTEVALUATION OF MEDICINAL PRODUCTS»OF THE MINISTRY OF HEALTH
  15. 15. Greatness is not inwhere we stand,but in whatdirection we aremovingOliver Wendell Holmes
  16. 16. Thank you for your attention

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