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Clinical Trials Act

consolidated text (as at 2017, amended since). juris shows the text as it was consolidated; it does not confirm that this is the law in force today.

Later amending instruments held: Finance (Miscellaneous Provisions) Act 2019 (Act No 13 of 2019), Finance (Miscellaneous Provisions) Act 2023 (Act No 12 of 2023), Finance (Miscellaneous Provisions) Act 2024 (Act No. 11 of 2024).

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Sections

  1. 1 Short title
  2. 2 Interpretation
  3. PART II: CLINICAL RESEARCH REGULATORY COUNCIL
  4. 3 Clinical Research Regulatory Council
  5. 4 Functions and powers of Council
  6. 5 Meetings of Council
  7. 6 Secretary and other officers of Council
  8. PART III: ETHICS COMMITTEE
  9. 7 Ethics Committee
  10. 8 Functions of Ethics Committee
  11. PART IV: PHARMACOVIGILANCE COMMITTEE
  12. 9 Pharmacovigilance Committee
  13. 10 Functions of Pharmacovigilance Committee
  14. PART V: TRIAL LICENCE
  15. 11 Trial licence
  16. 12 Application for trial licence
  17. 13 Grant of application
  18. 14 Refusal of application
  19. 15 Amendment of trial licence
  20. 16 Suspension or cancellation of trial licence
  21. PART VA: REGISTRATION CERTIFICATE
  22. 16A Registration certificate inserted by Act No 13 of 2019
  23. 16B Grant of application inserted by Act No 13 of 2019
  24. 16C Refusal of application inserted by Act No 13 of 2019
  25. 16D Suspension or cancellation of registration certificate inserted by Act No 13 of 2019
  26. PART VI: CONDUCT OF CLINICAL TRIALS
  27. 17 Good clinical practice
  28. 18 The sponsor
  29. 19 The investigator
  30. 20 Protection of subjects
  31. 21 Emergency measures
  32. 22 Strict liability of sponsor
  33. 23 Trial master file and archiving
  34. 24 Progress and completion of clinical trial reports
  35. 25 Completion and discontinuance of clinical trial
  36. PART VII: INSPECTIONS
  37. 26 Verification of compliance
  38. PART VIII: PHARMACOVIGILANCE
  39. 27 Record of adverse event or reaction
  40. 28 Notification of serious adverse event or reaction
  41. PART IX: REGISTER OF CLINICAL TRIALS
  42. 29 Register of clinical trials
  43. 29A Register of contract research organisations inserted by Act No 13 of 2019
  44. PART X: OFFENCES
  45. 30 Offences
  46. PART XI: MISCELLANEOUS PROVISIONS
  47. 31 Annual report
  48. 32 Powers of Minister
  49. 33 Disclosure of interest
  50. 34 Protection from liability
  51. 35 Regulations