New CTA regulations are applicable to all submissions, including amendments, in Poland. Submissions can no longer be done by a CRO but by a physical person, who can however be an employee of the CRO. Also two letters of authorisation are required, one from the sponsor authorising the legal representative and the second from the legal representative authorising the physical person in Poland. Less than 3 month old, proofs of establishment are needed for both the sponsor and the legal representative.

EMA announcement on pediatric clinical studies is soon to start functioning. The pan-EU network will be assisiting pharmaceutical companies with carrying out clinical trials in children in accordance with the agreed paediatric investigation plan…Link