Aifa Clinical Investigation Agreement For The Drugs

Aifa has indicated that in case of difficulties related to the COVID 19 emergency, the mandatory entry of data on treatments with monitored drugs via the online aifa registry can be postponed to a maximum of 90 days from 12 March 2020. This measure only applies to patients already under treatment registered on the AIFA platform and are in any case excluded from the launch of new treatments and the register of innovative medicines (in accordance with Article 1(404) of Law 232/2016 and available at the web address: www.aifa.gov.it/farmaci-innovativi) that already exist. Hematological analysis must be carried out in public institutions located near the patient`s residence. The carrying out of analyses carried out by unauthorized private bodies for clinical trials must be carefully weighed. They are allowed if it is the only way to protect patient safety. The use for regulatory purposes of data from laboratories not authorised for testing should be justified when transmitting the data. The guidelines allow clinical trials to be conducted outside control centers if necessary to limit the risk of coronavirus infection. In this case, the sponsors must notify the competent ethics committee of a substantial change in the immediate implementation, which sets out the urgency of the situation. In addition, sponsors and DCS should develop a risk assessment plan and implement an action plan to minimise contact between patients and teaching staff and avoid overloading healthcare facilities. The Italian Medicines Agency (AIFA) announced, on the 7th Submission of applications for authorisation for clinical trials Submission of applications and amendments Ethics Committees Management of study activity outside the imp study sites Clinical trials for patients Closed to the public Control of clinical trials Direct conclusion of contracts with specialists by sponsors Reimbursement of exceptional costs This is exceptionally allowed during the current EMERGENCY CO VID 19.

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