5 Amendments of Maria da Graça CARVALHO related to 2012/0192(COD)
Amendment 52 #
Proposal for a regulation
Recital 26
Recital 26
(26) In order for the sponsor to assess all potentially relevant safety information, the investigator should repcort to himd and register in the electronic database all serious adverse events.
Amendment 62 #
Proposal for a regulation
Article 2 – paragraph 2 – point 6
Article 2 – paragraph 2 – point 6
(6) ‘Normal clinical practiceBest current proven intervention’: the treatment regime typically followed to treat, prevent, or diagnose a disease or a disorder according to current reliable scientific evidence;
Amendment 72 #
Proposal for a regulation
Article 4 – paragraph 1 – subparagraph 1 (new)
Article 4 – paragraph 1 – subparagraph 1 (new)
Comparative clinical trials of new drugs shall be required against the best current proven intervention.
Amendment 132 #
Proposal for a regulation
Article 25 – paragraph 5 – subparagraph 1 (new)
Article 25 – paragraph 5 – subparagraph 1 (new)
Amendment 157 #
Proposal for a regulation
Article 78 – paragraph 1 – subparagraph 2
Article 78 – paragraph 1 – subparagraph 2
Public access to detailed and summary raw clinical data is particularly important to safeguard public health. The EU database shall contain the data and information submitted in accordance with this Regulation.