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The bill to expand scientific consultations and pre-registration for drug developers was rejected in first reading: a number of deficiencies were found in the initiative State Duma deputies decided to reject the bill to expand scientific consultations and pre-registration for drug developers - it was suggested that such functions be transferred to a state specialist institution. According to the presented initiative, developers planned to provide a paid consultation before submitting an application for drug registration. Experts will be able to assist in person, remotely or in writing during analytical tests, preclinical and clinical studies and in the preparation of registration documents. Bill No. 1215377-8 stated that recommendations of this type must then be included in the registration file and taken into account during the subsequent inspection. The legal department of the State Duma pointed out in the report a number of shortcomings in the document. For example, the project did not define clear boundaries between counseling and drug testing. The procedure for considering the recommendations and their legal consequences was also unclear. The State Duma Committee for Health Protection also recommended rejecting the initiative. Read us in Max Telegram VK.

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The bill to expand scientific consultations and pre-registration for drug developers was rejected in first reading: a number of deficiencies were found in the initiative State Duma deputies decided to reject the bill to expand scientific consultations and pre-registration for drug developers - it was suggested that such functions be transferred to a state specialist institution. According to the presented initiative, developers planned to provide a paid consultation before submitting an application for drug registration. Experts will be able to assist in person, remotely or in writing during analytical tests, preclinical and clinical studies and in the preparation of registration documents. Bill No. 1215377-8 stated that recommendations of this type must then be included in the registration file and taken into account during the subsequent inspection. The legal department of the State Duma pointed out in the report a number of shortcomings in the document. For example, the project did not define clear boundaries between counseling and drug testing. The procedure for considering the recommendations and their legal consequences was also unclear. The State Duma Committee for Health Protection also recommended rejecting the initiative. Read us in Max Telegram VK.

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