The Board of the Eurasian economic Commission approved The "guidelines for preclinical safety studies for clinical trials and registration of medicines". The guidelines establish common approaches to the selection of the type and duration of preclinical safety studies as a justification for the possibility of future safe conduct of human clinical trials. The document also eliminates differences in the scope…
The state Duma Committee on health protection approved the draft Federal law "on amendments to article 67 of the Federal law" on circulation of medicines " in terms of improving the implementation of the system of monitoring the movement of medicines for medical use. Currently, the bill is expected to be considered in the first reading. The draft provides that…
On 15 October, the Committee of the European Directorate for quality of medical products (EDQM) decided to suspend the certificate of suitability R1-CEP 2009-267-Rev 01 for the pharmaceutical substance "Erythromycin" and the certificate of suitability R0-CEP 2013-342-Rev 02 for the pharmaceutical substance "Bisoprolol fumarate" produced by "Meta Eypiay HTP".Ltd.", India ("Mehta API Pvt.Ltd."; Gut No.546,571,519 & 520, Kumbhavali Village Tarapur,…
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