18:59 02.11.2018

EBA urges Health Ministry to pay attention to systemic delays in approval of clinical trials

2 min read
EBA urges Health Ministry to pay attention to systemic delays in approval of clinical trials

The development of clinical research in Ukraine is hampered by delays in their approval, in particular, in the signing and publication of approval orders, according to the European Business Association (EBA).

"We focus on the need for the earliest possible study of this issue. We believe that the establishment of internal procedures for the approval of orders and the general optimization of the procedure in practice would indicate the consistency of state policy on the development of the sphere in future," the EBA said.

The association noted that the recent delay in signing and issuing orders approving research "was particularly tense and almost led to a breakdown in the study."

According to the EBA, delays in approvals, on average from 10 to 25 days, are too frequent, while orders from the Ministry of Health should be published within five days after the State Expert Center gives positive recommendations on approval of clinical examinations.

"A failure to comply with the deadline has long been of a systemic nature. Therefore in practice the companies that conduct clinical studies in Ukraine have to spend more time organizing a project in Ukraine at the last stage - obtaining approval from the Ministry of Health," the association noted.

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