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LEGISLATION IMPLEMENTATION – EXPERIENCE OF BELARUS PowerPoint Presentation
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LEGISLATION IMPLEMENTATION – EXPERIENCE OF BELARUS

LEGISLATION IMPLEMENTATION – EXPERIENCE OF BELARUS

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LEGISLATION IMPLEMENTATION – EXPERIENCE OF BELARUS

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  1. LEGISLATION IMPLEMENTATION – EXPERIENCE OF BELARUS Gennadi Vasilyevich Godovalnikov – Director RUE “Center for Expertise an Researches in Health Care”, candidate of pharmaceutical sciences

  2. CONTROLLING-PERMISSIVE SYSTEM OF DRUGS CIRCULATION Ministry of Health of Belarus Decision making Minister of Health Deputy Minister of Health Main Department for Pharmacy and medical equipment Republican Unitary Enterprise «Center for Expertise and Researches in Healthcare» Pharmacology Committee of the Ministry of Health Pharmacopoeia Committee of the Ministry of Health Development of draft decisions Commission on medical immune-biological drugs

  3. STRUCTURE OF RUE «CENTER FOR EXPERTISE AND RESEARCHES IN HEALTHCARE» Director Deputy Director on Drugs Deputy Director on medical equipment Deputy Director on on hygienic registration Drugs Department Department for Licensing and Inspection Department for medical equipment Department for hygienic regulations and registration Head of Department-Pharmacology Committee Secretary Deputy Head of Department-Pharmacopoeia Committee Secretary Republican reference and analytical laboratory Department Employees Pharmacology and Pharmacopoeia Committees’ experts

  4. CLINICAL TRIALS IMPLEMENTATION Total Number 199 (as of 26.09.2002)

  5. 1992 – INITIATION OF INDEPENDENT CLINICAL TRIALS OF DRUGS Clinical trials of drugs in Belarus

  6. BIOLOGICAL EQUIVALENCE TRIALS OF DRUGS

  7. 974 1000 900 779 800 700 600 476 500 400 300 217 213 204 200 122 87 100 0 Russia Belarus Germany India Poland France Hungary Latvia Total 5271 as of September 26, 2002 REGISTRATION OF DRUGS IN BELARUS

  8. Baltic countries 3% Belarus 15% Foreign production 50% CIS 32% Total5271 as of September 26, 2002 REGISTRATION OF DRUGS IN BELARUS

  9. LICENSING OF PHARMACEUTICAL ACTIVITIES Data as of 01.07.2002

  10. DRUGS QUALITY CONTROL Most often met drugs that were indicated as adulterated: 2000 - Nystatin tablets (7), Noshpatablets (5), Summamedpowder (3), Terzhinan vaginal tablets (8), Trichopol tablets (10) 2001-Biceptol tablets (17), Hystaktablets (5), Nystatin tablets (9), Trichopol tablets (9), Essencialle Н capsules (12), Festal dragee (13), Piprolet tablets (7), 9 months of 2002 года - Essencialle Н capsules (5),Mesim (8), Festal (8), Cyston (1), Trental (5)