32. development vector of regulatory procedures of biological medicines in russia

Development vector of regulatory procedures of biological medicines

in Russia

Elena Maksimkina Head of Department of state regulation of medicine, Ministry of Health Ph.D. (pharmacy) Moscow 15.05.2013

BIOTHERAPEUTIC MEDICINES

Development of formal institutes in the field of Health care in Russia

National project “Health”

Federal Law FZ-323 of 21.11.2011 “ On Fundamentals of Healthcare Protection of Citizens in the Russian Federation”.

Federal Law FZ-61 of 12.04.2010 “On the Circulation of Pharmaceuticals”

Strategy of the development of pharmaceutical industry until 2020

Concept of health care development until 2020

Programs of modernizing health care of the Russian Federation

Main areas of regulation

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Modifications de la loi fédérale « sur la distribution des médicaments »

Développement du cadre

conceptuel :

• médicaments biologiques

• médicaments bioanalogiques

• médicaments de référence

• médicaments génériques

Création des conditions pour un meilleur

contrôle officiel des prix des médicaments

Habilitation 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 médicale

des médicaments

• validation de règles pour un choix rationnel des noms des médicaments à

usage médical

Définition des

particularités de l'examen

de certains groupes de

médicaments

Introduction de la notion de

« médicaments orphelins » et

de leur procédure

d’homologation

Harmonisation avec la législation

internationale : • élaboration du dossier d’homologation

• introduction des normes de pratique

conforme clinique et pré-clinique

Need to Define the Regulation Object

62) Biological medicinal product is a medicinal product, the active substance of which is a pharmaceutical substance obtained or extracted from a biological source, and determination of properties and quality of which takes a combination of biological and physical/ chemical methods. Biological medicinal products include immune biological medicinal products, medicinal products derived from human and animal blood and plasma, biotechnological medicinal products, gene therapy and somatic cell therapy medicinal products;

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The proposed wording takes into account the problems with the maximum assessment of this group 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 biological medicinal 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.


71) Biotechnological medicinal product - a medicinal product that is manufactured through the stages using biotechnological processes, including recombinant DNA technology, the technology of controlled expression of genes coding biologically active proteins in procaryotes and eucaryotes, including modified mammal cells, hybrydoma antibody and monoclonal antibody technology;

72) Gene therapy medicinal product – a biological medicinal product, the pharmaceutical substance of 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 or includes cells or tissues with the biological features and physiological functions or structure modified for the intended use, or that represents or includes cells or tissues not intended for performance of the same basic functions in the recipient as in the donor

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122) Biosimilar medicinal product (biosimilar) – a biological medicinal product that is similar to the originator 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 generic medicinal product, if there is no originator medicinal product corresponding to it in the State Register of Medicinal Products;

123) Interchangeable medicinal product – a medicinal product, other than a biological medicinal product, with proven therapeutic equivalence to the originator medicinal product or the comparator medicinal product, which is used for the same indications (except for the indications, which are protected in the Russian Federation by applicable patents), has the same qualitative 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 for manufacturing of and quality control over medicinal products;

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Treatment Process Drivers

•State

•Physician

•Pharmacist

•Manufacturer –

(in particular, via the

institute of medical

representatives)

Reasons to Discuss Intercheangibility

1. 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 aspect

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Biological Medicinal Products Registered in the Russian Federation

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Group Number of SKUs (in particular, taking into account the

production site)

Foreign

Erythropoetins 20 8

Interferons 53 20

Monoclonal antibodies 42 37

Insulins 61 40

Somatropins 11 7

G-CSF 24 17

Heparins 55 25

Plasma coagulation factors 31 19

r-coagulation factors 9 3

FSBI «SCIENTIFIC CENTRE FOR EXPERT EVALUATION OF MEDICINAL PRODUCTS» OF THE MINISTRY OF HEALTH

The Scientific centre’s divisions on the map of Moscow

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For purposes of implementing the new state policy

regarding the circulation of medicinal products

(Federal law № 61-FZ, dated 12 May, 2010)

The institution’s legal organizational form and structure were changed

New functions and tasks were determined

State certification of experts was carried out

Scientific and methodological support for evaluation of quality, efficacy

and safety of medicinal products is constantly being improved


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Organizational structure

SCIENTIFIC CENTRE FOR EXPERT EVALUATION OF MEDICINAL PRODUCTS

ADMINISTRATIVE AND MANAGERIAL DIVISIONS

Quality assurance

department

SCIENTIFIC DIVISIONS

Centre for evaluation of medicinal products safety

Centre of pharmacopoeia and international

cooperation

Centre of clinical pharmacology

Centre of educational programs

Centre for planning and coordination of research

and development activities

EXPERT DIVISIONS

CENTRE OF FPP EXPERTISE

(5 boards)

TESTING CENTRE FOR EVALUATION

OF MEDICINAL PRODUCTS QUALITY

(11 laboratories)

CENTRE OF MIBP EXPERTISE

(3 boards)

TESTING CENTRE FOR EVALUATION OF MIBP QUALITY

(10 laboratories)

MIBP CERTIFICATION CENTRE

Management and organization department

Reference information: Staff numbers of the Institution – 900 employees Members of the Russian Academy of Medical Sciences – 4 Professors – 19 Doctors of Science – 56 Candidates of Science – 214

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Main functions of the FSBI “SCEMP”

assessment of applications for the registration of medicinal products in Russia and post-authorization variations filling of already registered medicinal products in respect of their quality, efficacy and safety;

evaluation of the pre-clinical trials' results and assessment of the possibility of carrying out clinical trials of medicinal products on the territory of Russia, including international multicentre clinical trials;

laboratory evaluation (testing) of medicinal products quality as part of their registration;

carrying out scientific research, working out guidance documents related to quality, efficacy and safety of medicinal products, drawing up pharmacopoeial monographs for the state pharmacopoeia, organization of training workshops

13 FSBI «SCIENTIFIC CENTRE FOR EXPERT EVALUATION OF MEDICINAL PRODUCTS» OF THE MINISTRY OF HEALTH

CENTRE OF PHARMACOPOEIA AND INTERNATIONAL

COOPERATION

Preparation of the first State Pharmacopoeia in the contemporary history of Russia (SPh

XII) – 5 parts

2008 - I part SPh XII

2011 - II part SPh XII – description of physical, physical-chemical and chemical methods of

analysis, pharmacotechnological tests

2012 - III part SPh XII – General pharmacopoeia monographs for immunobiological products

and methods of analysis, general requirements for dosage forms and medical products

2013 - IV part SPh XII – herbs and herbal medicinal products

2013-2014 - V part SPh XII – homeopathic medicines and methods of their analysis

Participation in the work of the European Pharmacopoeia Commission aimed at

international harmonization of quality standards of domestic medicinal products

Reference. The Russian Federation has a status of the Observer State in the European

Pharmacopoeia Commission

Elaboration of programs for harmonization of Russian national standards with normative

documents of the EU countries, the USA, and the CIS countries in the sphere of medicinal

products' evaluation

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Greatness is not in where we stand, but in what direction we are moving

Oliver Wendell Holmes

Thank you for your attention

32. development vector of regulatory procedures of biological medicines in russia

Health & Medicine