Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19

The International Coalition of Medicines Regulatory Authorities (ICMRA) convened a virtual meeting of regulators from around the world on 14 May 2020 to discuss high-level policy issues and regulatory requirements to respond to the ongoing COVID-19 pandemic. The strategic meeting underlined the need and commitment by global regulators to cooperate and align their approaches to […]

Chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes

Chloroquine and hydroxychloroquine, two medicines currently authorised for malaria and certain autoimmune diseases, are being investigated worldwide for their potential to treat coronavirus disease (COVID-19). However, efficacy in treating COVID-19 is yet to be shown in studies. It is very important that patients and healthcare professionals only use chloroquine and hydroxychloroquine for their authorised uses […]

Track legal obligations with the new EU Chemicals Legislation Finder

ECHA’s new online service, the EU Chemicals Legislation Finder (EUCLEF), gives companies access to a free-of-charge overview of 40 pieces of EU chemicals legislation they may need to comply with. With EUCLEF’s launch, information on 40 pieces of EU chemicals legislation is now easily accessible in one place, bringing clarity to companies, in particular for […]

Addressing the potential impact of novel coronavirus disease (COVID-19) on medicines supply in the EU

EMA and its partners in the European medicines regulatory network are closely monitoring the potential impact of the outbreak of the novel coronavirus disease (COVID-19) on pharmaceutical supply chains into the European Union (EU). No reports of current shortages or supply disruptions of medicines marketed in the EU due to this outbreak have been received […]

Sassoli: “We must make a commitment to the thousands of unaccompanied minors at Europe’s borders”

European Parliament President David Sassoli visited the Greek-Turkish border with European Commission President Ursula von der Leyen, European Council President Charles Michel, and Croatian Prime Minister Andrej Plenković, whose country holds the rotating Council Presidency. After the visit, President Sassoli stated: “It is important that all three Presidents of the European institutions travelled to the […]

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2020

Two new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended two medicines for approval at its February 2020 meeting. The Committee recommended granting a marketing authorisation for Fetcroja (cefiderocol) for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. The generic medicine Tigecycline Accord (tigecycline) received a […]

EUIPO must give a fresh decision on the application made by Constantin Film for registration of the sign Fack Ju Göhte as an EU trade mark

EUIPO and the General Court, which both found that the sign is contrary to accepted principles of morality, failed to take sufficient account of the fact that the title of a comedic film does not appear to have been perceived as morally unacceptable by the German-speaking public at large