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Image header Agence Europe
Europe Daily Bulletin No. 12357
Contents Publication in full By article 20 / 26
NEWS BRIEFS / Health

Commission guidelines on clinical trials of innovative medicinal products

25/10/2019 (Agence Europe) – On Thursday, 10 October, the European Commission published guidelines for clinical trials on advanced therapy medicinal products (ATMPs) conducted in the EU. In the guidelines, the Commission states that these medicinal products must comply with the principles of the International Council for the Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), but their properties must sometimes be indicated in order to address the distinctive features of innovative medicinal products, such as their short lifespan. The fifteen-page document therefore tackles this task. Link to the document: http://bit.ly/2MJmncD (SPj)

Contents

SECTORAL POLICIES
CLIMATE: EU Council adopts its position on revision of MRV regulation for ship emissions
CLIMATE: success for first replenishment of Green Climate Fund, with $9.8 billion pledged
ENVIRONMENT: rewriting Drinking Water Directive, endocrine disrupters, a bone of contention between European Parliament and EU Council negotiators
TRANSPORT: six Member States call on EU to reassess proposals related to ‘mobility I’ package
FOOD SAFETY: EU identifies problems in US system for monitoring residues in animal products
REGIONS: European Parliament adopts amendments to EUSF fund in the event of a no-deal Brexit
JUSTICE: Commission makes a positive assessment of European judicial training strategy
ENERGY: election of first Board of Directors of Batteries Europe
INSTITUTIONAL
EUROPEAN COMMISSION: Ursula von der Leyen meets Hungarian and French candidate Commissioners
ECONOMY - FINANCE - BUSINESS
TAXATION: white smoke of agreement has not been spotted at EU Council on fiscal transparency by country
FINANCE: Commission lacks vision and methodology to develop pan-European venture capital, according to European Court of Auditors
STATE AID: opening of an investigation into Polish support for renovation of district heating networks
EXTERNAL ACTION
TRADE: reconciling trade and climate policy will pose extremely difficult challenges, Commission acknowledges
SINGAPORE: implementation of free trade agreement with Singapore imminent
CHINA: negotiations of EU/China agreement on geographical indications likely close to their conclusion
DEVELOPMENT: green light from Member States for estimated contributions to be paid to 11th EDF
COURT OF JUSTICE OF THE EU
JUSTICE: reference for a preliminary ruling on evidence obtained in breach of right to respect for private life considered inadmissible
NEWS BRIEFS
BOLIVIA: EU recommends holding second round of presidential elections
ENERGY: negotiations on Russian gas transiting through Ukraine to enter their fourth phase
HEALTH: Commission guidelines on clinical trials of innovative medicinal products
PALESTINE: EU ready to sign agreement allowing Palestinian Authority to participate in certain programmes
FOOD SAFETY: France can improve its control system for tuna products
PLANTS: Italy invited to improve control of Red neck longhorn beetle, a pest
The B-word: Agence Europe’s newsletter on Brexit
THE B-WORD: Stop all the clocks
CALENDAR
Main activities of European Institutions: from 28/10 to 03/11/2019
CALENDAR EXTRA
Other Events: until 10 November 2019