Clinical Studies in Eastern Europe - DGRA 2020-01-26آ  for clinical research in Eastern Europe...

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Transcript of Clinical Studies in Eastern Europe - DGRA 2020-01-26آ  for clinical research in Eastern Europe...

  • Clinical Studies in Eastern Europe: critical assessment of the regulatory requirements

    Wissenschaftliche Prüfungsarbeit Scientific Thesis

    zur Erlangung des Titels to obtain the degree

    „Master of Drug Regulatory Affairs“

    der Mathematisch-Naturwissenschaftlichen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn at the Faculty of Mathematics and Natural Sciences,

    Rhenish Friedrich-Wilhelms-University Bonn (Germany)

    vorgelegt von submitted by

    Anna Volodina, MsIH

    aus Voronezh, Rußland born in Voronezh, Russia

    Bonn 2010

  • Betreuerin und 1. Referentin: Dr. Ingrid Klingmann Supervisor and 1st Assessor: 2. Referent: Dr. Ekkehard Baader 2nd Assessor:

  • i

    Table of Contents:

    Acknowledgement……………………………………...……………………………….….. iv

    List of Abbreviations………………………………………………………………………....v

    CHAPTER 1: INTRODUCTION…………………………………..…………….…………..1

    1.1 Eastern Europe as emerging market in clinical research..……….…………...……….…1

    1.1.1. Eastern European countries chosen for the study………………………………….…..2

    1.2 Study objectives….………...…………………….……….………………………….…...4

    1.3 Methods of data collection………...………………………………….……………….....5

    CHAPTER 2: CLINICAL RESEARCH IN RUSSIA……………………………………….6

    2.1 Overview of major national legislation in clinical research……………………………...6

    2.2 Main regulatory procedures………………………………………………………………7

    2.2.1 Clinical trial authorization…………………………………………………………..7

    2.2.2 Notification of amendments………………………………………………………...9

    2.2.3 Declaration of the end of the trial………………………………………………….10

    2.3 Ethical principles in clinical research…………………………………………………...10

    2.3.1 Structure of the Ethics Committees and review procedure………………………..10

    2.3.2 Clinical research in vulnerable populations……………………………………….11

    2.4 Customs regulations on IMP and human biological material…………………………..12

    CHAPTER 3: CLINICAL RESEARCH IN BELARUS…………………………………...13

    3.1 Overview of major national legislation in clinical research……………………………13

    3.2 Main regulatory procedures…………………………………………………………….14

    3.2.1 Clinical trial authorization………………………………………………………...14

    3.2.2 Notification of amendments………………………………………………………16

    3.2.3 Declaration of the end of the trial…………………………………………………16

    3.3 Ethical principles in clinical research…………………………………………………..16

    3.3.1 Structure of the Ethics Committees and review procedure……………………….16

    3.3.2 Clinical research in vulnerable populations………………………………………21

    3.4 Customs regulations on IMP and human biological material………………………….22

    CHAPTER 4: CLINICAL RESEARCH IN MOLDOVA………………………………….22

    4.1 Overview of major national legislation in clinical research……………………………22

    4.2 Main regulatory procedures…………………………………………………………….24

  • ii

    4.2.1 Clinical trial authorization ………………………………………………….……..24

    4.2.2 Notification of amendments……………………………………………………….24

    2.2.3 Declaration of the end of the trial………………………………………………….25

    4.3 Ethical principles in clinical research…………………………………………………...25

    4.3.1 Structure of the Ethics Committees and review procedure…………………….….25

    4.3.2 Clinical research in vulnerable populations………………………………….……26

    4.4 Customs regulations on IMP and human biological material…………………………..27

    CHAPTER 5: CLINICAL RESEARCH IN KAZAKHSTAN……………………………...27

    5.1 Overview of major national legislation in clinical research…………………………….27

    5.2 Main regulatory procedures……………………………………………………………..29

    5.2.1 Clinical trial authorization…………………………………………………………29

    5.2.2 Notification of amendments……………………………………….………………31

    5.2.3 Declaration of the end of the trial………………………………………….………31

    5.3 Ethical principles in clinical research…………………………………………….……..31

    5.3.1 Structure of the Ethics Committees and review procedure………………………..31

    5.3.2 Clinical research in vulnerable populations……………………………………….32

    5.4 Customs regulations on IMP and human biological material…………………………..32

    CHAPTER 6: SURVEY RESULTS…………………………………………………….…..33

    CHAPTER 7: DISCUSION…………………………………………………………………36

    CHAPTER 8: CONCLUSIONS AND RECOMMENDATIONS………………….…....….41

    CHAPTER 9: SUMMARY………………………………………..………………………..42

    REFERENCES………………………………………………………………….…...….......45

    ANNEXES…………………………………………………………………………………..49

    1. Joint table on documents required for clinical trial application to competent authority...49

    2. Joint table on documents required for clinical trial application to ethics committee…….51

    3. Flowchart on clinical trial approval procedure in Russia………………………….……..52

    4. Flowchart on clinical trial approval procedure in Belarus…..…………………………...53

    5. Flowchart on clinical trial approval procedure in Moldova………………………….…..54

  • iii

    6. Flowchart on Clinical trial approval procedure in Kazakhstan………………………..…55

    7. Open Letter……………………………………………………………………………….56

    8. Questionnaire for the competent authorities……………………………………………...58

    9. Questionnaire for the Pharmaceutical Industry and CROs……………………………….60

  • iv

    ACKNOWLEDGEMENT

    I would like to express my deepest gratitude to all individuals and organizations that helped

    me to conduct this study.

    I express sincere thanks to the German Society for Regulatory Affairs (DGRA) for

    providing financial support during the whole period of my study in the Master of Drug

    Regulatory Affairs course at the Friedrich-Wilhelms-Universität Bonn, Germany.

    I am very thankful to my thesis supervisor Dr. Ingrid Kingmann, Chair of the Clinical

    Research Module in the Master of Drug Regulatory Affairs course, Friedrich-Wilhelms-

    Universität Bonn and the Board Member of the European Forum for Good Clinical Practice.

    I am grateful to her for providing constant support, inspiring me and being a wonderful

    tutor.

    I am indebted to Prof. Dr. Olga Kubar, the EFGCP Board member, Education Officer and

    Ex-Chair of the FECCIS for her guidance and help in carrying out the survey.

    My appreciation to all regulatory specialists from pharmaceutical companies and competent

    authorities participated in the survey, who have devoted their time to respond to my

    questions, despite of the intensive working schedule. This study could never been done

    without their sincere participations.

    Finally, I thank my family for believing in me and being proud of my work.

  • v

    List of Abbreviations:

    CIS Commonwealth of Independent States

    CRO Contract Research Organization

    CTA Clinical Trial Application

    CTP Clinical Trial Protocol

    EC Ethics Committee

    FDA Food and Drug Administration

    FECCIS Forum for Ethics Committees in the Confederation of Independent States

    EMA European Medicines Agency

    IB Investigator’s Brochure

    IMP