LEGISLATIVE FRAMEWORK

  • Order of the Minister of Health of the Republic of Kazakhstan №142 dated April 2 , 2018
  • The Civil Code of the Republic of Kazakhstan, the Code of the Republic of Kazakhstan dated December 27, 1994 No. 268-XIII.;
  • The Code of the Republic of Kazakhstan "On the health of the people and the healthcare system";
  • Helsinki Declaration of the World Medical Association, adopted at the 64th General Assembly of the World Medical Association, Fortaleza, Brazil, October 2013;
  • Order of the Minister of Health of the Republic of Kazakhstan dated November 19, 2009 No. 744 "On approval of the Rules for conducting clinical trials and (or) tests of pharmacological and medicinal products, medical devices and medical equipment".
  • Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated May 27, 2015 No. 392 "On approval of appropriate pharmaceutical practices", Annex 2.
  • On Approval of the Rules of Good Clinical Practice of the Eurasian Economic Union, Decision of the Council of the Eurasian Economic Commission No. 79 of November 3, 2016;
  • About the Rules for conducting clinical and clinical laboratory tests (studies) Medical devices, Decision of the Council of the Eurasian Economic Commission No. 29 of February 12, 2016;
  • On Approval of the Rules for Conducting Research of Biological Medicines of the Eurasian Economic Union, Decision of the Council of the Eurasian Economic Commission No. 89 dated November 3, 2016;
  • On Approval of the Rules for Conducting Bioequivalence Studies of Medicines within the Framework of the Eurasian Economic Union, Decision of the Council of the Eurasian Economic Commission No. 85 of November 3, 2016;
  • Convention on Human Rights and Biomedicine (1997);
  • Recommendations of the World Health Organization to Ethics Committees conducting the Examination of Biomedical Research (2000);
  • Guidelines on the quality of clinical trials of medicines, medical devices and medical equipment;
  • Regulations on the conduct of CI;