10 Amendments of Rebecca TAYLOR related to 2012/0192(COD)
Amendment 102 #
Proposal for a regulation
Recital 9 b
Recital 9 b
(9b) The concept of 'Normal Clinical Practice' is of vital importance in determining whether an application is authorised as a 'low intervention clinical trial'. The definition of 'Normal Clinical Practice' should be clarified by the Commission in guidelines.
Amendment 110 #
Proposal for a regulation
Recital 10
Recital 10
(10) The assessment of the application for a clinical trial should address in particular the anticipated therapeutic and public health benefits (‘'relevance’)'), and the risk and inconveniences for the subject. Regarding the relevance, numerous aspects should be taken into account, including; in later trial phases this should include whether the trial subjects are representative of the population for whom the medicinal product is targeted, and whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products.
Amendment 175 #
Proposal for a regulation
Recital 62 a (new)
Recital 62 a (new)
(62a) According to the Commission Communication on "An Integrated Industrial Policy for the Globalisation Era-Putting Competitiveness and Sustainability at Centre Stage", systematic evaluation of legislation should become an integral part of smart regulation. To ensure that this Regulation keeps pace with scientific, technological and medical progress with regard to the organization and conduct of clinical trials and that it interfaces with other legal provisions, the Commission should periodically report on the experience with and functioning of the Regulation, and present its conclusions to the Parliament and Council.
Amendment 220 #
Proposal for a regulation
Article 2 – paragraph 2 – point 7
Article 2 – paragraph 2 – point 7
Amendment 291 #
Proposal for a regulation
Article 6 – paragraph 1 – point a – point i – indent 2
Article 6 – paragraph 1 – point a – point i – indent 2
– the relevance of the clinical trial, ensuring that the trial participants are representative of the target population for the medicinal product, taking account of the current state of scientific knowledge, and of whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products;
Amendment 316 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point c
Article 6 – paragraph 4 – subparagraph 1 – point c
Amendment 361 #
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. Where, regarding Part I of the assessment report, the clinical trial is acceptable or acceptable subject to conditions, the Member State concerned shall include in its decision its conclusion on Part II of the assessment report. The Member State concerned shall submit both Part I and Part II of the assessment report, including their conclusions, to the sponsor.
Amendment 399 #
Proposal for a regulation
Article 14 – paragraph 3 – point c
Article 14 – paragraph 3 – point c
Amendment 538 #
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 2 a (new)
Article 34 – paragraph 3 – subparagraph 2 a (new)
In the event of non-compliance by the sponsor with the obligation referred to in paragraph 3, financial penalties shall be imposed by the Member State concerned. The Commission shall produce guidelines for Member States on the consistent application of such financial penalties.
Amendment 603 #
Proposal for a regulation
Article 55 – paragraph 1
Article 55 – paragraph 1
Unless other Union legislation requires archiving for a longer period, the sponsor and the investigator shall archive the content of the clinical trial master file for at least fivetwenty years after the end ofconcluding the clinical trial. However, the medical files of subjects shall be archived in accordance with national legislation. If the sponsor is unable to archive the master file, it may be archived with the Agency.