2 Amendments of Tomáš ZDECHOVSKÝ related to 2016/2169(DEC)

Benedek JÁVOR, Tomáš ZDECHOVSKÝ, Bart STAES

Motion for a resolution
Paragraph 14 a (new)

14a. Reminds the Agency that Directive 2003/63/EC states that medicines can only be considered for Union marketing authorisation if they have been tested according to ethical guidelines, and reminds the Agency of its commitment to perform extra checks on clinical trials carried out outside the European Union before granting a drug market authorisation 1a ; therefore, due to the special vulnerabilities of those tests, asks the Agency to report to the Discharge Authority every year on actions taken to ensure drugs for the Union Market were tested ethically in lower and middle income countries, in accordance with the law; _________________ 1a Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted outside of the EU/EEA and submitted in marketing authorisation applications to the EU Regulatory Authorities http://www.fercap- sidcer.org/publications/pdf/201205/08- FERCAP-21- EMA%20Reflection%20Paper%20on%20 Ethical%20and%20GCP%20Aspects%20 of%20Clinical%20Trials.pdf

2017/03/06
Committee: CONT

Benedek JÁVOR, Tomáš ZDECHOVSKÝ, Bart STAES

Motion for a resolution
Paragraph 23 a (new)

23a. Notes that the Agency launched a pilot project on "adaptive pathways" in March 2014 aiming to accelerate market authorisations for specific medicines using the so-called post-marketing authorisation; is concerned that the pilot project raises numerous public health concerns and undermines the core mission of the Agency, namely to ensure safety of medicines; asks the Agency to report to the Discharge Authority on the project and the measures it has taken to ensure that this acceleration of the procedure does not undermine its core mission;

2017/03/06
Committee: CONT

2 Amendments of Tomáš ZDECHOVSKÝ related to 2016/2169(DEC)

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