Bulgarian Drug Agency and OCABR Lyubina Gaydarova Director Blood, Blood Donation and Blood Transfusi

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Bulgarian Drug Agency and OCABR Lyubina
GaydarovaDirector Blood, Blood Donation and
Blood Transfusion Bulgarian Drug Agency - BDA
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History of the Bulgarian Drug Agency

• 1904 - establishment of Chemical laboratory to
  the Department for protection of public health
  with the obligation to control and investigate
  the medicines in the country, including for
  scientific and forensic purposes.
• 1954 foundation of the State Institute for
  Control of Medicines (SICM)
• 1992 transformation of SICM to the National
  Drugs Institute (NDI)
• December 1999 - transformation of NDI into the
  Bulgarian Drug Agency (BDA)

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• The Bulgarian drug agency (BDA) is a specialised
  body of the Ministry of health for supervision
  and surveillance of the quality, efficacy and
  safety of medicines.
• BDA is a corporate body financed from the state
  budget. It is based in Sofia
• The structure, responsibilities and organization
  of work of BDA are defined in a structural
  regulation adopted by the Council of Ministers.

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Main responsibilities of BDA

• manufacturing authorisation of medicinal products
  and GMP certification
• marketing authorisation and registration of
  medicinal products
• authorisation for wholesale distribution for
  medicinal products
• parallel importation authorisation
• registration of drugstores
• authorisation of clinical trials of medicinal
  products
• authorisation for advertising of medicinal
  products

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• supervision of the manufacture, importation,
  storage, wholesale distribution, retail, clinical
  trials, safety and advertising of medicinal
  products
• laboratory testing in case of suspected deviation
  from the quality, efficacy and safety of
  medicinal products, including follow-up measures
• organisation of a pharmacovigilance system
• certification according to the WHO certification
  scheme
• co-ordination and participation in Pharmacopoeia
  activities
• supervision of blood, blood components, blood
  donation and transfusion.

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Personnel

• Permanently appointed personnel according to the
  Structural Regulation
• 145 persons
• Biological products Directorate 16
• (of which laboratory sector
• 3 graduated
• 2
  technicians)

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• Following the Agreement Bulgaria to join the EU
  several alterations had to be done in the
  National Pharmaceutical legislation 3
  directions
• Adoption of a new Law on Human Medicinal Products
  (13.04.2007)
• Adoption of a Law on Medical Devices
• Ammendment of the Law on Blood, Blood Donation
  and Blood Transfusion

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• Main Goals of Legislative Alterations
• Harmonisation of the National Legislation with
  the European Directives
• Building up an adequate administrative and
  financial capacity as well as trained personnel

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• New Pharmaceutical Legislation came into force
  since 13th April 2007

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After Adoption of Law on Medicinal Products

• BDA tasks concern the preparation of
• - 26 Regulations
• - BDA Structural Regulation BDA staff will
• increase from 145 to 172
• - Quality Assurance System
• - Risk Management System
• - Participation in BEMA
• - Transparency System

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Batch release

• Before 13.04.2007 (date of publication and coming
  into force of the new Law on medicinal products
  for human use) batch release of vaccines and
  blood products was based on examination of
  manufacturing and testing protocols submitted by
  the manufacturer. Testing by the BDA for batch
  release has been done on rare occasions.
• According to the new Law every batch of a
  vaccine, an immunological product intended to be
  used for immunisation and a medicinal product
  derived from human blood or plasma before
  marketing has to be submitted to OCABR based on
  testing in an accredited laboratory.

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Locally produced vaccines and blood products in
Bulgaria

• Vaccines
• BCG
• TT
• DT
• Td
• DTPw
• Crimean haemorrhagic fever

• Human blood derivatives
• Albumin
• Anti-D immunoglobulin
• Anti-Staphylococcus immunoglobulin
• Anti-Crimean Hemorrhagic fever immunoglobulin
• Normal immunoglobulins
• Normal immunoglobulinhistamine dihydrochloride

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Vaccines and blood products in Bulgaria from
third countries

• No vaccines
• Blood derivatives
• Coagulation factor VIII (USA)
• Anti-D immunoglobulin (USA)
• Fibrinogen (China)
• Prothrombin complex concentrate (China)
• Normal immunoglobulin (China)

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Vaccines and blood products in Bulgaria from
Member States

• Various vaccines and products derived from human
  blood or plasma,
• detailed list in PA/PH/OMCL (07) 13 R

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Marketing of vaccines and blood products in
Bulgaria batches released from another Member
State

• Batch release certificate from releasing OMCL
  marketing information form
• ? if no formal objection within 7 days, the batch
  may be marketed

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Vaccines and blood products from local production
and from third countries - OCABR

• Current situation BDA is not able to do the
  majority of the tests necessary for batch release
  due to lack of laboratory facilities, equipment
  and trained personnel.
• Plans for the future BDA is in the process of
  acquisition of a new building, where the
  facilities needed for batch release testing will
  be established. Funding for the new building and
  purchase of equipment is included in the budget.

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BDA Financing

• Budget
• 2004 - 1 812 047 BGN
• 2005 - 1 840 700 BGN
• 2006 - 2 393 501 BGN
• 2007 - 3 518 841 BGN
• 2 000 000 BGN for BDA new building
• 1 500 000 BGN for BDA Control
  Laboratory
• 1 BGN 0.5128 Euro

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Vaccines and blood products from local production
and from third countries - OCABR

• In the mean time ?
• Probably
• Some tests will be done by the BDA (e.g.
  appearance, identity of toxoids and BCG,
  molecular size distribution of immunoglobulins
  and albumin)
• Some tests will be subcontracted to a laboratory
  accredited by the Bulgarian office for
  accreditation (e.g. anti-HIV-1 and 2, HCV by NAT)

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Vaccines and blood products from local production
and from third countries - OCABR

• In the mean time ?
• Probably
• Some samples will be sent for testing to other
  OMCLs
• Some tests needed for OCABR will not be done (in
  this case release certificates will be issued
  based on examination of manufacturers production
  and testing protocols partial testing this
  release certificates will not be EU OCABR
  certificates)

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Contact info

• Official site of BDA - www.bda.bg
• General Executive - Emil Hristov,MD
  hristov_at_bda.bg
• Secretary General Georgi Georgiev, MD, PhD
  georgiev_at_bda.bg
• Lyubina Gaydarova,MD (blood products) -
  lyubina_g_at_bda.bg 
• Poly Popova, MD, PhD (vaccines)- poly_at_bda.bg

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Thank you for your attention!