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“The approaches to the regulation of biological medicinal products in the Republic of Kazakhstan” Illustrates the current norms in place in Kazakhstan for the marketing authorization of pharmaceutical products and the dossier requirements for biotherapeutics & biosimilarsTRANSCRIPT
The approaches to the regulation of biological medicinal products in the Republic of Kazakhstan
The National Center for Drug Expertise, Medical items and EquipmentMinistry of Public HealthRepublic of Kazakhstan
Sh. BaidullayevaHead of Department for Pharmacological Assessment
15-16 мая 2013, МоскваБиотерапевтические препараты. Современные вызовы и регуляторные практики. Подходы к
гармонизации.
Pharmaceutical marketing authorization pathway in Kazakhstan
MPhACC’s** as a regulatory body Kazakhstan Ministry of Public health
MPhACC’s** as a regulatory body Kazakhstan Ministry of Public health
The National Center for Drug Expertise, Medical items and Equipment’s on expert body in medicinal products regulation
Registration dossier
Ministry of Public H
ealth
Registration dossier
assessment
Marketing authorization’s based on positive
conclusions of the NCDE*
*NCDE - The National center for drug expertise, medical items and equipment
**MPhACC - the Medical and Pharmaceutical activity control Committee
NCDE’s main unitsMedicinal product Medical devices
Primary expertise department Primary expertise department
Department for Pharmaceutical Assessment
Department for Medical devices Assessment
Department for Pharmacological Assessment
Labs
Physical Chemistry Lab
Microbiologically Lab
Republican immunobiological lab
Pharmacological Lab/BA&BE Lab
Animal house
Group on non-clinical&clinical studies
Department for quality&safety assessment (certification)
11 regional branches
http://www.dari.kz
Pharmaceutical marketing authorization rules have been defined by:
the Kazakhstan Health Code (18.09.2009)
the MoH Orders under №735 (18.11.2009) and 736 (18.11.2009)
Registration dossier assessmentRegistration dossier assessment by NCDE consists of 4 consecutive
stages:1) primary expertise – the main aim’s to check the registration dossier completeness for meeting current requirements, adequacy of the finished product and reference standards samples for a three-time analysis
2) analytical tests at the test lab –the aim’s to perform tests for checking the quality of FPS to be in conformity with an Analytical normative document developed in accordance with Finished product specification and Kazakhstan Pharmacopeia, EPh, USP, BP
3) pharmaceutical assessment – it’s an expertise of pharmaceutical part of the dossier, namely development pharmaceutical form, manufacturing, impurities assessment, data stability, etc.
4) pharmacological assessment – it’s an expertise conducted for pharmacological part of the dossier, namely non-clinical studies&clinical trials data, pharmacovigilance , Risk management plan
BiosimilarsUp to September, 2009, there hadn’t been any requirement for marketing authorization of biosimilars in Kazakhstan
In the Kazakhstan Health Code the first definition of “biosimilars” was accepted only in September, 2009
Definitions “Biological medicinal product” and “Biosimilars”
Biological medicinal products are the products containing biological proteins (hormones, cytokines, blood clotting factors, including low molecular weight heparin, insulin, monoclonal antibodies, enzymes, colony stimulating factors, products that have been developed on the basis of tissue cells obtained by genetic engineering and hybridoma technology)
Biosimilars is a reproduced biological medicinal product that is claimed to be similar in quality, safety and efficacy to innovative reference biological medicinal product with a similar international non-proprietary name that has been registered before
The Kazakhstan Health Code of Republic (18.09.2009)
Dossier Requirements
For marketing authorization of the original medicinal product, including immunotherapeutic and radiopharmaceutical products, an applicant for registration provides the whole list for the required registration dossier
MoH Order under №735 dated 18/11/2009,paragraph 15
Dossier Requirements for biosimilar It is necessary to provide the following data for biosimilar marketing authorization:
- active substance and finished product of biosimilar quality data compared with the original biological product
-reports on comparative preclinical studies of biosimilar and original biological product
-reports on biosimilar safety, efficacy and immunogenicity through comparative clinical trials versus original biological product
- Pharmacovigilance Master File marketing authorization holder and Risk management plan for the proposed product
MoH Order under №735 dated 18/11/2009,paragraph 23
Kazakhstan record book makes 7131 medicinal products by 10th May 2013, with it all 296 is biological medicinal products
Registered under the following biological product groups:VaccinesInsulinMonoclonal antibodyErythropoietin Low-molecular-weight heparinsInterferonGranulocyte-colony stimulating factorSomatropin
The following product brackets have been applied for registration as biosimilrs from 2010 to 2012
Active substance name Number application Decision
Peg interferon (India) 1 Refused
Erythropoietin (Korea) 1 Refused
Low-molecular-weight heparin (India)
2 Refused
Somatropin (Russia) 1 Refused
Interferon beta (Ukraine) 1 Refused
Refusal for registration
- No proof for quality, purity and potency similarity with the reference biological product
- The lack of comparative non-clinical studies&clinical trials
- Multi-reference for different stages of product development (quality tests, preclinical and clinical studies)
- The lack of Risk management plan
The following product brackets have been applied for registration as biosimilrs in 2013
Active substance name Number application
Decision
Low-molecular-weight heparin (India) 1 Under review
The monoclonal antibody - Infliximab (Korea)
1 Under review
The monoclonal antibody Rituximab (India)
1 Under review
Reference Biological medicinal product
The original biological product is the reference product
In case of non-availability of the original biological product in Kazakhstan, there is an option to regard the authorized products in the ICH-countries
National Center for Drug Expertise makes use of European Medicines Agency guidelines over biosimilar registration dossier
assessment
The reproduced Insulin products Marketing authorization was granted before September, 2009, for some insulin products (India, Ukraine, Poland)
However they are not considered as biosimilars and are not use in clinical practice
Amendments to authorization requirements
Reproduced biological medicinal products registered earlier than 2009, upon maturity deadline will be submitted for registration, however not for re-registration , in accordance with biosimilars requirements
Draft Amendment to MoH Order №735
Thank you for attention!
Thank you for attention!
Charyn Canyon