Ukraine. Clinical trials
Clinical trials of medicinal products shall be conducted according to the Decree of the MHC of Ukraine dd. 23.09.2009 #690 «On approval of the Procedure for conduction of clinical trials of medicinal products and expert examination of clinical trials’ materials and the Standard provision on Ethics Commission».
All clinical trials shall be conducted according to international ethical principles ensuring protection of rights, safety and well-being of participants. Clinical trial can be conducted only if the expected advantage justifies possible risks. Clinical trials shall be conducted in medico-prophylactic institutions having a medical license and accreditation certificate issued by the MHC of Ukraine or any other body authorized by it.
The choice of investigators as well as medico-prophylactic institutions is the function of the sponsor (a legal entity or an individual responsible for initiation and organization of the clinical trial and its financing).
Conclusion on conduction of the clinical trial is provided by the Centre. Upon results of the expert examination of materials the Centre provides a positive conclusion or gives a reasonable refusal as to conduction of the clinical trial. The conclusion of the Centre shall be approved by the MHC of Ukraine.
Approval of the clinical drug trial is granted by the Central Ethics Commission. Local ethics commissions shall ensure adherence to ethical norms during clinical trials in medico-prophylactic institutions.
It shall be noted that the Procedure for conduction of clinical trials approves main requirements as to protection of study subjects, in particular as to provision of information on the clinical trial to patients (healthy volunteers) and obtaining of an informed contest; detailed regulation of the process of the clinical trials with participation of minors and under-aged patients, disabled persons who are not capable to give informed consent on their own.
Besides, the Procedure stipulates requirements to investigators and medico-prophylactic institutions as well as main requirements as to marking of study drugs.
Study drugs not used during the clinical trial shall be utilized according to requirements of the current legislation or returned to the sponsor.
All clinical trials shall be conducted according to international ethical principles ensuring protection of rights, safety and well-being of participants. Clinical trial can be conducted only if the expected advantage justifies possible risks. Clinical trials shall be conducted in medico-prophylactic institutions having a medical license and accreditation certificate issued by the MHC of Ukraine or any other body authorized by it.
The choice of investigators as well as medico-prophylactic institutions is the function of the sponsor (a legal entity or an individual responsible for initiation and organization of the clinical trial and its financing).
Conclusion on conduction of the clinical trial is provided by the Centre. Upon results of the expert examination of materials the Centre provides a positive conclusion or gives a reasonable refusal as to conduction of the clinical trial. The conclusion of the Centre shall be approved by the MHC of Ukraine.
Approval of the clinical drug trial is granted by the Central Ethics Commission. Local ethics commissions shall ensure adherence to ethical norms during clinical trials in medico-prophylactic institutions.
It shall be noted that the Procedure for conduction of clinical trials approves main requirements as to protection of study subjects, in particular as to provision of information on the clinical trial to patients (healthy volunteers) and obtaining of an informed contest; detailed regulation of the process of the clinical trials with participation of minors and under-aged patients, disabled persons who are not capable to give informed consent on their own.
Besides, the Procedure stipulates requirements to investigators and medico-prophylactic institutions as well as main requirements as to marking of study drugs.
Study drugs not used during the clinical trial shall be utilized according to requirements of the current legislation or returned to the sponsor.
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