2020/2157(DEC) 2019 discharge: European Medicines Agency (EMA)
Lead committee dossier:
Progress: Awaiting committee decision
Role | Committee | Rapporteur | Shadows |
---|---|---|---|
Lead | CONT | CZARNECKI Ryszard ( ECR) | CHRISTOFOROU Lefteris ( EPP), RÓNAI Sándor ( S&D), CSEH Katalin ( Renew), EICKHOUT Bas ( Verts/ALE), OMARJEE Younous ( Confederal Group of the European United Left) |
Committee Opinion | ENVI | CANFIN Pascal ( Renew) |
Lead committee dossier:
Subjects
Events
2021/03/04
EP - Amendments tabled in committee
Documents
2021/02/05
CSL - Supplementary non-legislative basic document
Documents
2021/02/01
EP - Committee opinion
Documents
2021/01/14
EP - Committee draft report
Documents
2020/09/15
EP - Committee referral announced in Parliament, 1st reading/single reading
2020/09/10
EP - CANFIN Pascal (Renew) appointed as rapporteur in ENVI
2020/09/08
EP - CZARNECKI Ryszard (ECR) appointed as rapporteur in CONT
2020/06/29
EC - Non-legislative basic document
Documents
2020/06/29
EC - Non-legislative basic document published
Documents
Documents
- Amendments tabled in committee: PE680.787
- Supplementary non-legislative basic document: 05793/2021
- Committee opinion: PE660.255
- Committee draft report: PE657.226
- Non-legislative basic document: COM(2020)0288
- Non-legislative basic document: EUR-Lex
- Non-legislative basic document published: COM(2020)0288
- Non-legislative basic document published: EUR-Lex
- Non-legislative basic document: COM(2020)0288 EUR-Lex
- Committee draft report: PE657.226
- Committee opinion: PE660.255
- Supplementary non-legislative basic document: 05793/2021
- Amendments tabled in committee: PE680.787
Amendments | Dossier |
7 |
2020/2157(DEC)
2020/12/16
ENVI
7 amendments...
Amendment 1 #
Draft opinion Paragraph 5 5. Acknowledges the impact of the United Kingdom’s decision to withdraw from the European Union on the EMA's activities and the resulting additional expenditure, amounting to EUR 51,44 million, including the staff, office and workspace costs related to
Amendment 2 #
Draft opinion Paragraph 9 9. Takes note that the EMA received 20 reports of improprieties from an external source in 2019 and that 13 of the cases received in 2019 and 11 cases received in previous years were closed; calls on the EMA to analyse the causes of those improprieties;
Amendment 3 #
Draft opinion Paragraph 10 10.
Amendment 4 #
Draft opinion Paragraph 10 a (new) 10a. Welcomes the efforts of EMA to increase transparency around its activities, in particular the efforts made in favour of significantly simplified clinical trials reporting for universities and hospitals and other improvements that have led to more clinical trials resultsbeing reported;
Amendment 5 #
Draft opinion Paragraph 10 b (new) 10b. Calls on the EMA to continue increasing the level of transparency around its activities; in particular calls on the EMA to resume as soon as possible its policy on the publication of clinical data for medicinal products for human use (‘Policy 0070’) which was suspended in December 2018 and has still not been reinstated today;
Amendment 6 #
Draft opinion Paragraph 10 c (new) 10c. Notes with concern that the EMA still does not authorise requests for access to documents via email and regrets that long delays of more than a year are the norm in terms of answering those requests; calls on the EMA to publicly set, and comply with, clear timeframes for responding to such requests from now on;
Amendment 7 #
Draft opinion Paragraph 10 d (new) source: 660.425
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