Activities of Antonyia PARVANOVA related to 2012/0192(COD)
Plenary speeches (1)
Clinical trials on medicinal products for human use (debate)
Shadow reports (1)
REPORT 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 PDF (1 MB) DOC (2 MB)
Amendments (25)
Amendment 86 #
Proposal for a regulation
Recital 4
Recital 4
(4) Directive 2001/20/EC aimed to simplify and harmonise the administrative provisions governing clinical trials in the European Union. However, experience shows that a harmonised approach to the regulation of clinical trials has only been partly achieved. This makes it in particular difficult to perform a clinical trial in several Member States. Scientific development however, suggests that future clinical trials will target more specific patient populations, such as subgroups identified through genomic information. In order to include a sufficient number of patients for such trials it may be necessary to involve many, or all, Member States. The new procedures for the authorisation of clinical trials should stimulate the inclusion of as many member states as possible. Therefore, in order to simplify submission procedures, the multiple submission of largely identical information should be avoided and replaced by the submission of one application dossier through a single submission portal to all the Member States concerned. Given that clinical trials carried out in a single Member State are equally indispensable to European clinical research, the procedure under this regulation should also cover such trials. The application dossier for such clinical trials should also be sent via the single European portal.
Amendment 94 #
Proposal for a regulation
Recital 8
Recital 8
(8) The timelines for assessing an application dossier for clinical trials should be sufficiently long to assess the file, while ensuring quick access to new, innovative as well as, existing (e.g. generic medicinal products) treatments and ensuring that the Union remains an attractive place for conducting clinical trials. Against this background, Directive 2001/20/EC introduced the concept of tacit authorisation. This concept should be maintained in order to ensure that timelines are adhered to. In the event of a public health crisis, Member States should have the possibility to assess and authorise a clinical trial application swiftly. No minimal timelines for approval should therefore be established.
Amendment 103 #
Proposal for a regulation
Recital 9 c
Recital 9 c
(9 c) Clinical studies supporting the registration of generic medicinal products (e.g. bioequivalence or therapeutic equivalence studies) pose minimal risks and inconveniences for the study subjects compared to the normal clinical practice, as defined in this Regulation, since the reference medicinal product, used as comparator, is a well-characterised authorised product for which the quality safety and efficacy have already been assessed.
Amendment 107 #
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, includingsuch as the subpopulations to be studied and the potential differences in efficacy and/or safety for specific subpopulations notably gender and age differences, or 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 111 #
Proposal for a regulation
Recital 10 a (new)
Recital 10 a (new)
Amendment 119 #
Proposal for a regulation
Recital 14
Recital 14
(14) It should be left to the Member State concerned to determine the appropriate body or bodies to be involved in this assessment. This decision is a matter of internal organisation of each Member State. Member States, when determining the appropriate body or bodies, should ensure the involvement of lay persons and patients. They should also ensure that the necessary expertise is available. In any case, however, and in accordance with international guidelines, the assessment should be done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience. The persons assessing the application should be independent from the sponsor, the institution of the trial site, and the investigators involved, as well as free of any other undue influence. Names, qualifications and declarations of interest of the persons assessing the application should be made publicly available.
Amendment 133 #
Proposal for a regulation
Recital 27
Recital 27
(27) The sponsor should assess the information received from the investigator, and immediately report safety information on serious adverse events which are suspected unexpected serious adverse reactions to the Agency via the electronic database referred to in Article 36.
Amendment 139 #
Proposal for a regulation
Recital 31
Recital 31
(31) The individuals involved in conducting the clinical trial, in particular investigators and other healthcare staffprofessionals, should be sufficiently qualified to perform their tasks in a clinical trial and the facilities where the clinical trial is to be conducted should be suitable for the clinical trial.
Amendment 158 #
Proposal for a regulation
Recital 46
Recital 46
(46) In clinical trials with non-authorised investigational medicinal products, or where the interventionith authorised investigational medicinal products used outside the terms of the marketing authorisation in a treatment regimen distinct from the standard of care, or where the diagnostic procedure poses more than an insignificant risk to subject safety, compensation should be ensured for damages successfully claimed in accordance with the applicable laws.
Amendment 170 #
Proposal for a regulation
Recital 52 b (new)
Recital 52 b (new)
(52b) Results of clinical trials, as well as clinical trial data, represent a relevant and valuable source of information for the continuation of biomedical or public health research on a medicinal product or active principle, and should be made available in order to support and foster the development of independent research related to a medicinal product and its clinical, pharmacological or other pharmacodynamic effects, or to its relative efficacy and effectiveness. The authorisation status of a medicinal product should however be duly considered before releasing data from clinical trial, in order not to disrupt the marketing authorisation process or the competition dynamics operating on the EU market while fostering attractiveness and long term viability of the EU based clinical research.
Amendment 171 #
Proposal for a regulation
Recital 52 c (new)
Recital 52 c (new)
(52c) Access to, release and processing of clinical trial data for medicines once the decision-making process on an application for a marketing authorisation is complete should be without prejudice to the protection of personal data, and should respond to specific guidelines in order to define and guarantee good analysis practice, clinical trial data formats, rules of engagement as well as other legal aspects. Such guidelines should promote an optimal level of transparency and public information, while ensuring the development of reliable scientific research and avoiding bias or misuse of information.
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 227 #
Proposal for a regulation
Article 2 – paragraph 2 – point 14
Article 2 – paragraph 2 – point 14
(14) ‘Investigator’: an individual physical person who is trained or has experience to a level equivalent to the stipulations of Article 46 of this Regulation and who is responsible for the conduct of a clinical trial at a clinical trial site;
Amendment 239 #
Proposal for a regulation
Article 2 – paragraph 2 – point 29
Article 2 – paragraph 2 – point 29
(29) ‘Serious adverse event’: any untoward medical occurrence, or other event deemed serious by the investigator in the context of the trial, that at any dose requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect, is life-threatening or results in death;
Amendment 358 #
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 3
Article 8 – paragraph 2 – subparagraph 3
Where the Member State concerned disagrees with the conclusion on the basis of point (a) of the second subparagraph, it shall communicate its disagreement, together with a detailed justification based on scientific and socio-economic arguments, and a summary thereof, through the EU portal to the Commission, to all Member States, and to the sponsor. The reasons for disagreement should be made publicly available.
Amendment 369 #
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Member States shall ensure that the persons validating and assessing the application do not have conflicts of interest, are independent of the sponsor, the institution of the trial site and the investigators involved, as well as free of any other undue influence. The names and declarations of interests of the persons validating and assessing clinical trial applications shall be made publicly available.
Amendment 540 #
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 2 a and 2 b (new)
Article 34 – paragraph 3 – subparagraph 2 a and 2 b (new)
For medicinal products which have been granted a marketing authorisation or for which the decision-making process on an application for a marketing authorisation is complete, the sponsor shall submit to the EU database the clinical study report of the clinical trial. The Commission, in cooperation with the Agency, shall be empowered to adopt delegated acts in accordance with Article 85, with regards to the public access to the clinical study report and other related clinical trial data, in order to define rules of engagement, clinical data formats and good analysis practice.
Amendment 547 #
Proposal for a regulation
Article 36 – paragraph 1
Article 36 – paragraph 1
The European Medicines Agency established by Regulation (EC) No 726/2004 (hereinafter, the ‘Agency’) shall set up and maintain an electronic database for the reporting provided for in Articles 38 and 39. That electronic database shall be a module of the database referred to in Article 25 of Regulation (EC) No 726/2004.
Amendment 554 #
Proposal for a regulation
Article 38 – paragraph 1
Article 38 – paragraph 1
1. The sponsor shall report electronically and without delay to the electronic database referred to in Article 36 all relevant information about suspected unexpected serious adverse reactions to investigational medicinal products insofar as the suspected unexpected serious adverse reaction occurred in a clinical trial conducted by the sponsor, or occurred in a clinical trial related to the sponsor, in accordance with time limits set out in Annex III, points 2.4 and 2.5.
Amendment 558 #
Proposal for a regulation
Article 38 – paragraph 2
Article 38 – paragraph 2
2. The time period for reporting shall take account of the severityriousness of the reaction. Where necessary to ensure timely reporting, the sponsor may submit an initial incomplete report followed up by a complete report.
Amendment 566 #
Proposal for a regulation
Article 39 a (new)
Article 39 a (new)
Article 39a Reporting of efficacy defect on authorised medicinal products Regarding authorised medicinal product which, according to the protocol, are used in accordance with the terms of the marketing authorisation, the investigator should inform the sponsor and the Agency of any observed efficacy defect related to the investigational medicinal product.
Amendment 567 #
Proposal for a regulation
Article 40 – paragraph 1
Article 40 – paragraph 1
1. The Agency shall, by electronic means, forward to the relevant Member States the information reported in accordance with Article 38, 39 and 39a.
Amendment 573 #
Proposal for a regulation
Article 41 – paragraph 1
Article 41 – paragraph 1
1. Regarding authorised medicinal products which, according to the protocol, are used in accordance with the terms of the marketing authorisation, the sponsor shall inform at least annually the marketing authorisation holder of all suspected serious adverse reactions, in addition to safety reporting obligations for authorised medicinal products as per Directive 2001/83/EC and Regulation (EC) No 726/2004.
Amendment 574 #
Proposal for a regulation
Article 43
Article 43
Safety reporting with regard to auxiliary medicinal products shall be made by the investigator in accordance with Chapter 3 of Directive 2001/83/EC.
Amendment 604 #
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 twenty five years after the end of the clinical trial and, where a marketing authorisation has been granted for the investigational medicinal product tested, based on the clinical trial results, throughout the marketing authorisation life of any of the active principles having been investigated. However, the medical files of subjects shall be archived in accordance with national legislation.