5. Dr. Yuri Gamazin - Ministry of Health (Ukraine)
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5. Dr. Yuri Gamazin - Ministry of Health (Ukraine)

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“The regulatory landscape for biotech products in Ukraine” ...

“The regulatory landscape for biotech products in Ukraine”

Illustrates the current norms in place in Ukraine for the marketing authorization of pharmaceutical products and the dossier requirements for biotherapeutics & biosimilars

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  • Quality is everybody’s responsibility, from the Director to the laboratory cleaner. The role of the quality manager is to establish a quality system and a quality culture in which everyone is motivated – and able – to contribute to the ultimate goal of the NCA/NCL , which is to provide an adequate supply of safe bioproducts for all patients who require it. For a quality system to work effectively, all staff need to recognize that ‘Quality Starts with Me’.

5. Dr. Yuri Gamazin - Ministry of Health (Ukraine) 5. Dr. Yuri Gamazin - Ministry of Health (Ukraine) Presentation Transcript

  • Ukrainian State Expert CenterMinistry of Health of UkraineThe regulatory landscape forbiotech products in UkraineYuriy Gamazin,Moscow, May, 2013
  • OBJECTIVE: The Objective of the National Programme of Ukrainian legistationharmonization with the European Union approved by Law of UkraineNo.1629-IV of March 18, 2004 is to achieve compliance of the legalsystem of Ukraine with acquis communautaire taking into account thecriteria set by the EU for the countries intended to join the EU. Thus, the objective of the MOH is to harmonise Ukrainian regulationson quality, safety and efficacy of medicinal products with theDirectives of the European Parliament and the European Councilrelating to registration and circulation of medicinal products.
  • Medicinal products are allowed for use in Ukraine after theirstate registration, except as provided by this LawLaw of Ukraine «On Medicines», 1996(Section ІІ, Article 9)Medicinal product can not be placed on the market of aMember State unless a marketing authorization has beenissued by the competent authorities of that Member State inaccordance with this Directive or an authorization has beengranted in accordance with Regulation (EEC) No 2309/93.Directive 2001/83 of the European Parliament and theEU Council of November 06, 2001(Title ІІІ, Chapter 1, Article 6)Prerequisites for the use of medicinal productsPrerequisites for the use of medicinal products
  • Essential regulations for medicinal productcirculation Law of Ukraine “On Medicines”; Resolution of the Cabinet of Ministers of Ukraine No 376 “On Approval ofthe Procedure for State Registration (Re-registration) of MedicinalProducts and Fee for Their State Registration (Re-Registration)” of May26, 2005 (as amended by Resolution of the CMU No 717 of June 27,2012); Resolution of the Cabinet of Ministers of Ukraine No. 73 “On Approval ofthe Regulation on the Control of Conformity of immunobiologicalProducts Used in Medical Practice with the Requirements of Nationaland International Standards” of January 15, 1996; Resolution of the CMU No 902 “On Approval of the Procedure for StateQuality Control of Medicinal Products Imported to Ukraine” ofSeptember 14, 2005
  • Essential regulations for medicinal productcirculation Order of the MOH of Ukraine No 426 “On Approval of the Procedurefor Conducting Expert Evaluation of Materials Pertinent to MedicinalProducts which are Submitted for State Registration (Re-Registration) and Expert Evaluation of Materials about Introduction ofChanges to the Registration Documents during the Validity Period ofRegistration Certificate" of August 26, 2005, (as amended by Order ofthe MOH of Ukraine No 3 of January 04, 2013; Procedure for State Quality Control of Medicinal ImmunobiologicalRroducts that are Used, Manufactured or Proposed for Use in MedicalPractice in Ukraine approved by Order of the MOH No 486 ofDecember 06, 2001
  • REGISTRATIONOF MEDICINAL PRODUCTS
  • Resolution of the CMU No. 717 of June 27, 2012 State registration of medicinal products and medicinal immunobiological productsunder unified procedure with taking into account particularities (Ministry of theHealth of Ukraine shall conduct state registration and re-registration of medicinalproducts under procedure set forth for medicinal products). The state registration of a medicinal immunobiological product is certified by aregistration certificate of the medicinal product (medicinal immunobiologicalproduct), not by a certificate of the state registration of the medicinalimmunobiological product; The MOH can decide to completely or temporarily prohibit the use of a medicinalproduct by terminating the registration certificate if the medicinal product was notreleased into circulation in the territory of Ukraine within two years from the dateof the state registration (re-registration) unless it is due to particularities ofmanufacture and/or use of such medicinal product.
  • Order of the MOH No. 3 of January 04, 2013Objective: Conformity with the acts of higher legal force (Law ofUkraine “On Medicines”, Resolution of the CMU No 376 of May 26,2005); improvement of the registration procedure in general. Revision of definitions; The proposed Order of the MOH is the single document for medicinesand medical immunobiological products; Strengthening the role of the MOH as the regulatory authority thatconducts the state registration of medicinal products and designatesthe registration procedure in accordance with the recoomendations ofthe expert body (The State Expert Center);
  • Order of the MOH No 3 of January 04, 2013 Revision of the Section relating to amending registration materials,classification of the types of changes; Submission, in the course of expert evaluation of the medicinalproduct registration materials, a copy of a document confirming thecompliance of manufacture with the requirements of GoodManufacturing Practice (GMP) that are in force in Ukraine, issued bythe State Administration of Ukraine on Medicinal Products (fordomestic manufacturers, a copy of the valid drug manufacturinglicense shall be provided); Bringing the requirements for medicinal product labeling in line withArticle 12 of the Law of Ukraine “On Medicines”; Regulation of terms of the registration procedure
  • Order of the MOH No. 3 of January 04, 2013 Requirements as to orphan drugs and specifics of their registrationmaterials; Definition of criteria and procedure for conducting additional studiesof medicinal products relating to:pharmaceutical development,confirmation of medicinal product quality,preclinical studies,medicinal product efficacy and/or safety studies,studies of bioequivalence and equivalence of generic medicinalproducts
  • Order of the MOH No 3 of January 04, 2013 Requirements as to equivalence (interchangeability) studies of generics,in particular: when in vivo equivalence study is not required; when equivalence study is required; conditions for biowaiver procedure; general aspects of test for dissolution; requirements for bioequivalence studies for different pharmaceuticalforms; requirements for confirmation of bioequivalence of additional doses ofthe medicinal product; report on bioequivalence studies
  • Order of the MOH No 3 of January 04, 2013 Special requirements are provided for registration of originalmedicinal products and medicinal products that underwent the WHOpre-qualification procedure and are included in the WHO list of pre-qualified medicinal products used in treatment of socially dangerousdiseases (tuberculosis, HIV / AIDS, viral hepatitis, and rare diseases): Modules 1 and 2 (and their translation into Ukrainian of Russian) in hard copy.Modules 3, 4, and 5 may be submitted by the applicant in soft copy; Expert evaluation of registration materials takes precedence and is conductedfree of charge; Pre-registration quality control of such medicinal products may be performedunder «Lot Release» procedure; Expert evaluation of the registration materials shall take not more than 90working days from the date of receipt of the registration dossier by the Center
  • Order of the MOH No 3 of January 04, 2013Control under «Lot Release» procedure is performed in the followingcases: the medicinal product is of high cost (equivalent to 500 EUR or more)and is imported to Ukraine in limited amounts; Sterility, Microbiological purity, or other parameters are evaluatedunder this procedure if their testing requires large number of specimensand the cost of one specimen is equivalent to 100 EUR or more; if none of the authorized laboratories has at disposal the equipmentrequired for performing control tests for certain quality parameters; the medicinal product is of limited use (orphan drug).
  • Biosimilars in Ukrainian legislationMedicinal immunobiological products include allergens, antigens, vaccines(anatoxins), cytokines, immunomodulators of bacterial origin, as well asthose that are based on organ and tissue preparations, productsobtained from human blood and plasma, immune sera, immunoglobulins(including monoclonal antibodies) , probiotics, interferons, other medicalproducts intended for use in medical practice for treatment, specificprevention and diagnosing the immune status (in vivo). They areproduced by cultivation of microorganism strains and eukaryotic cells,extraction of substances from biological tissues, including tissues ofhuman, animals and plants (allergens), and methods of geneticengineering, hybrid technologies, reproductions of alive agents inembryos or animals.(Resolution of the CMU No 73; Order of the MOH No. 426 (as amended byOrder No. 3)
  • Biosimilars in Ukrainian legislation Similar biological medicinal product (biosimilar) is a biological medicinalproduct which efficacy, safety and quality are similar to those ofregistered reference biological product which patent protection hasexpired. Similarity of therapeutic efficacy, safety and quality of suchmedicinal product to those of the reference medicine should beconfirmed with respective pre- and clinical studies.(Order of the MOH No 426 (as amended by Order No 3)
  • Biosimilars in Ukrainian legislationSpecial requirements to biosimilars are introduced :In case of registration of similar biological products (biosimilars) thatcannot be considered generics due to the specificity of the manufacturingprocess, raw materials used, characteristics of the molecular structure andtherapeutic effects, in addition to Modules 1, 2, and 3 additional data are tobe provided to support the appropriate level of safety (toxicological or otherpreclinical studies) and efficacy (clinical trials) (Chapter 3, Section Х of thisProcedure)(paragraph.6.6 of Section VI, Chapter 3 of Section Х, Order of the MOH No426 (as amended by Order No 3))
  • Biosimilars in Ukrainian legislationNew chapter “Special requirements for the registration dossier materials ofsimilar biological medicinal products (biosimilars)” has been addedWhen applying for registration of a similar biological medicinal product afterthe expiration of the patent protection of data relating to the originalbiological product registered before, the following materials are to beprovided:information submitted should not be limited to Modules 1, 2 and 3(pharmaceutical, chemical and biological data), supplemented withbioequivalence and bioavailability data. The type and amount of additionaldata (i.e., toxicological and other preclinical and relevant clinical data) shallbe determined in each individulal case in accordance with the relevantrequirements and guidelines;
  • Biosimilars in Ukrainian legislationNew chapter “Special requirements for the registration dossier materials ofsimilar biological medicinal products (biosimilars)” has been addeddue to the diversity of biological medicinal products it may be necessary toprovide information on the identification studies provided for in Modules 4and 5 of the registration dossier, with due regard being had to the specialcharacteristics of each medicinal product.If the original medicinal product registered has more than one therapeuticindication, the efficacy and safety of a similar biological medicinal productshall be confirmed or, if necessary, demonstrated individually for each ofthe claimed indications.
  • STATE CONTROL OF MEDICINALPRODUCTS
  • Main Regulations Resolution of the Cabinet of Ministers of Ukraine No. 73 “On Approval ofthe Regulation on the Control of Conformity of ImmunobiologicalProducts Used in Medical Practice with the Requirements of Nationaland International Standards” of January 15, 1996; Resolution of the CMU No 902 “On Approval of the Procedure for StateQuality Control of Medicinal Products Imported to Ukraine” ofSeptember 14, 2005; Procedure for State Quality Control of Medicinal ImmunobiologicalRroducts that are Used, Manufactured or Proposed for Use in MedicalPractice in Ukraine approved by Order of the MOH No 486 of December06, 2001
  • State Control Procedure State control is mandatory for all products both domestic and foreignmanufacture that are used, manufactured or proposed for use in medicalpractice in the territory of Ukraine. Control is carried out by expert evaluation of the materials of the(manufacturers) quality control of the product batches (protocols ofbatch quality control, analytical reports) and laboratory testing of theproduct specimens in accordance with the specifications in theprescribed form and with the established regularity of the state control. Conclusion on MIP quality conformance is a basis for further circulationof the biolobical product, including its marketing.Order of the MOH No 486
  • Form and Frequency of State Quality Control of MIPsConductedConducted based on:based on: whether the product is registered in Ukraine;whether the product is registered in Ukraine; use of the product in the state programs, includinguse of the product in the state programs, including the program ofthe program ofvaccination in Ukraine;vaccination in Ukraine; availability of a copy of an official document of compliance of theavailability of a copy of an official document of compliance of themanufacture with GMP requirements issued by a competent authority ofmanufacture with GMP requirements issued by a competent authority ofUkraine or Japan or a member country of Pharmaceutical InspectionUkraine or Japan or a member country of Pharmaceutical InspectionCooperation Scheme (PIC / S);Cooperation Scheme (PIC / S); Data of side and non-specific effects monitoringData of side and non-specific effects monitoring;; Data on stability of the qualityData on stability of the quality parametersparameters for the period of the productfor the period of the productuse in medical practice in Ukraine.use in medical practice in Ukraine.
  • Forms of State ControlForms of State Control Detailed quality control: control of all the batch qualityDetailed quality control: control of all the batch qualityparameters in accordance with the specifications and methodsparameters in accordance with the specifications and methodsof quality control;of quality control; SelectiveSelective quality control: control of selected quality parametersquality control: control of selected quality parametersof the product batches.of the product batches.
  • Conclusion of MIConclusion of MIBBP quality conformance issued by theP quality conformance issued by theMinistry of Health is a result of the state control ofMinistry of Health is a result of the state control ofthe MIthe MIBBP batchP batchOrder of the MOH No 486 of December o6, 2001Order of the MOH No 486 of December o6, 2001Resolution of the CMU No 73 of January 15, 1996Resolution of the CMU No 73 of January 15, 1996Certificate of approval of a biological product issued by aNational authority on quality assurance for biologicalproductsWHO Technical Report Series, No.822, 1992 GuidelinesWHO Technical Report Series, No.822, 1992 Guidelinesforfor national authorities on quality assurance for biologicalnational authorities on quality assurance for biologicalproductsproductsProcedure for state control of biologicalproducts
  • Thank youfor attention!