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EMA committed on medicines and vaccines development

The European Medicine Agency (EMA) has adopted a series of procedures to speed up the approvals of treatments and vaccines to fight the COVID-19 pandemic.

In particular, the Task Force of experts set up by the Agency is working in strict cooperation with the Committee for Medicinal Products for Human Use (CHMP) to ensure quick feedbacks on procedures.

The EMA scientific advice – a procedure usually taking 40 to 70 days – is now provided for free in 20 days. Time to approve Paediatric Investigation Plans (PIPs) and the control of their compliance was also reduced from 120 to 20 days.

However EMA stressed that such rapidity can be ensured only in case of accurate dossiers, that can be agreed contacting the Agency before their submission.

The Agency can also avail themselves of rolling reviews to assess data of a promising potential drug as they become available as well as of accelerated assessments allowing the completion of the review of medicinal products of great interest for public health in 150 days instead of 210.