Activities of Emma McCLARKIN related to 2012/0192(COD)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Amendments (21)
Amendment 55 #
Proposal for a regulation
Recital 64 a (new)
Recital 64 a (new)
(64a) According to the Commission Communication on "An Integrated Industrial Policy for the Globalisation Era Putting Competitiveness and Sustainability at Centre Stage" systematic evaluations of legislation must become an integral part of smart regulation. In order to ensure this Regulation keeps pace with scientific and technological progress in the organization and conduct of clinical trials and interfaces with other legal provisions, the Commission should periodically report on the experience and functioning of the Regulation and present its conclusions thereof.
Amendment 72 #
Proposal for a regulation
Article 2 – paragraph 2 – point 11 a (new)
Article 2 – paragraph 2 – point 11 a (new)
(11a) 'Reporting Member State': the Member State coordinating and documenting the assessment of an application for authorisation or of a substantial modification involving three or more Member States, which has been submitted under Chapters II and III of this Regulation.
Amendment 105 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – introductory part
Article 6 – paragraph 4 – subparagraph 1 – introductory part
For the purposes of this Chapter, the assessment date shall be the date on which the assessment report is submitted to the other Member States concerned and the reporting date shall be the date when the final assessment report is submitted to the sponsor and to the other Member States concerned. The reporting Member State shall submit Part I of the assessment report, including its conclusion, to the sponsor and to the other Member States concerned within the following time periods:, which shall include periods for initial assessment, for joint assessment and for consolidation of the final report.
Amendment 106 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point a
Article 6 – paragraph 4 – subparagraph 1 – point a
(a) within 10 days from the validation date for low-intervention clinical trials; the time for the joint assessment and for consolidation by Member States concerned and the reporting Member State shall not be shorter than 5 days;
Amendment 107 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point b
Article 6 – paragraph 4 – subparagraph 1 – point b
(b) within 25 days from the validation date for clinical trials other than low- intervention clinical trials; the time for the joint assessment and for consolidation by Member States concerned and the reporting Member State shall not be shorter than 10 days;
Amendment 108 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point c
Article 6 – paragraph 4 – subparagraph 1 – point c
(c) within 30 days from the validation date for any clinical trial with an advanced therapy investigational medicinal product; the time for the joint assessment and for consolidation by Member States concerned and reporting Member State shall not be shorter than 10 days.
Amendment 109 #
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. Until the assessment date, any the reporting Member State shall develop and circulate to the Member States concerned an initial assessment report. No later than 2 days before the reporting date, the Member States concerned may communicate to the reporting Member State and all other Member States concerned any considerations relevant to the application. The reporting Member State shall take those considerations duly into account in finalising the assessment report.
Amendment 112 #
Proposal for a regulation
Article 6 – paragraph 6 – subparagraph 1
Article 6 – paragraph 6 – subparagraph 1
The reporting Member State, and only the reporting Member State, may, between the validation date and the assessmentreporting date, request additional explanations from the sponsor, taking into account the considerations referred to in paragraph 5.
Amendment 113 #
Proposal for a regulation
Article 6 – paragraph 6 – subparagraph 2
Article 6 – paragraph 6 – subparagraph 2
For the purpose of obtaining those additional explanations, the reporting Member State may suspextend the time period referred to in paragraph 4 for a maximum of 120 days for low-intervention clinical trials and for a maximum of 230 days for trials other than low-intervention clinical trials.
Amendment 114 #
Proposal for a regulation
Article 6 – paragraph 6 – subparagraph 3
Article 6 – paragraph 6 – subparagraph 3
Amendment 115 #
Proposal for a regulation
Article 6 – paragraph 6 – subparagraph 5 a (new)
Article 6 – paragraph 6 – subparagraph 5 a (new)
The reporting Member State may also extend the time referred to in paragraphs 4 and 6a further 60 days for trials involving Advanced Therapy Medicinal Products or other novel therapies, for the purpose of consulting with expert committees.
Amendment 134 #
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. In the assessment, the view of at least one person whose primary area of interest is non-scientific shall be taken into account. The view of at least one patient shall be taken into account. An independent Ethics Committee as referred to in the Declaration of Helsinki and ICH-GCP shall be involved in the assessment of each clinical trial.
Amendment 140 #
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
2. TheWhere there was a reporting Member State for the application referred to in paragraph 1initial authorisation procedure it shall be the reporting Member State for the initial authorisation procedureapplication referred to in paragraph 1.
Amendment 158 #
Proposal for a regulation
Article 32 – paragraph 1 – point a
Article 32 – paragraph 1 – point a
(a) due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical condition, it is impossible to obtain prior informed consent from the subject or its legal representative (parent or guardian) and it is impossible to supply prior information to the subject or its legal representative (parent or guardian);
Amendment 161 #
Proposal for a regulation
Article 32 – paragraph 1 – point c
Article 32 – paragraph 1 – point c
(c) the subject or legal representative has not previously expressed objections known to the investigator;
Amendment 163 #
Proposal for a regulation
Article 32 – paragraph 1 – point e
Article 32 – paragraph 1 – point e
(e) the clinical trial poses a minimal risk to, and imposes a minimalonly a proportionate risk with reference of the underlying medical condition (life threatening disease), and imposes only a proportionate burden on, the subject.
Amendment 180 #
Proposal for a regulation
Article 39 – paragraph 1 a (new)
Article 39 – paragraph 1 a (new)
Amendment 181 #
Proposal for a regulation
Article 39 – paragraph 2
Article 39 – paragraph 2
2. The obligation for a particular sponsor, referred to in paragraph 1, starts with the first authorisation of a clinical trial in accordance with this Regulation for that sponsor. It ends with the end of the last clinical trial conducted by the sponsor with the investigational medicinal product. The annual reporting obligation does not apply when a sponsor is not currently conducting any clinical trials with the investigational medicinal product.
Amendment 194 #
Proposal for a regulation
Article 76 – paragraph 1 – point a
Article 76 – paragraph 1 – point a
Amendment 195 #
Proposal for a regulation
Article 78 – paragraph 3 – indent 2
Article 78 – paragraph 3 – indent 2
– pProtecting commercially confidential information in particular through taking into account the authorization status of the product;
Amendment 197 #
Proposal for a regulation
Article 93 – paragraph 2
Article 93 – paragraph 2
It shall apply as from [please set a specific date - two years after its publication]once the full functionality of the EU Portal has received a positive opinion from the Standing Committee on Medicinal Products for Human Use.