3 Amendments of Stanislav POLČÁK related to 2023/2156(DEC)
Amendment 16 #
Draft opinion
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Notes that in March, the EMA started to operate under a new extended mandate which recognises the role played by the Agency during the pandemic and gives it additional responsibilities in the area of coordination and crisis response; notes, in this context, that it is essential to ensure funding commensurate with this extended mandate in the future;
Amendment 18 #
Draft opinion
Paragraph 9 b (new)
Paragraph 9 b (new)
9b. Notes that this extended mandate also provides the framework for the creation of DARWIN EU, a model for gathering real evidence from across the EU on diseases, populations and the use and efficacy of medicines and vaccines throughout their lifecycle; sees this as a potentially major change in medicines regulation;
Amendment 20 #
Draft opinion
Paragraph 9 c (new)
Paragraph 9 c (new)
9c. Welcomes the fact that 52% of applicants who have been granted a positive opinion for their medicinal product have received scientific advice or protocol assistance from the EMA during the development phase of their product, with this figure rising to 78% for applicants for medicinal products with new active substances; is of the opinion that early advice has the potential to significantly streamline the approval process and lead to the development of safe and effective medicinal products;