Tag Archives: Clinical Trials

Commission Publishes Further Guidance on Clinical Trial Conduct During COVID-19 Pandemic

On 28 April 2020, the European Commission published further Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic (the “Guidance”), supported by the European Medicines Agency (EMA) and the national Heads of Medicines Agency (HMA).  The Guidance is an update to the previous version published in late March (see InsideEULifeSciences blog post … Continue Reading

Ireland’s HPRA to fast-track review of Covid-19 related Clinical Trials and Clinical Investigations

The Irish Health Products Regulatory Authority (HPRA) today announced the introduction of an expedited review process for human health research related to COVID-19. The Irish Minister for Health also announced the setting up of a dedicated COVID-19 National Research Ethics Committee (NREC-COVID-19). Applications for clinical trials of human medicines or clinical investigations of medical devices … Continue Reading

EMA Publishes Guidance on Clinical Trial Conduct During COVID-19 Pandemic

On 20 March 2020, the European Medicines Agency (EMA) published Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic (the Guidance).  The EMA jointly developed the Guidance with working groups from the European Commission and the national Heads of Medicines Agency (HMA). The Guidance provides information on changes and protocol deviations that … Continue Reading

The Implications of the GDPR on Clinical Trials in Europe

On October 22, 2018, the European Federation of Pharmaceutical Industries in cooperation with the Future of Privacy Forum and the Center for Information Policy Leadership organized a workshop entitled “Can GDPR Work for Health Research.”  In the first session, the workshop discussed the implications of the General Data Protection Regulation (“GDPR”) on clinical trials in … Continue Reading

Another round of upcoming amendments to the medicines laws in Germany – Clinical Trials, Advertising, Biologics and more…

On 11 November 2016, the German Parliament passed another new law amending different parts of the German Medicines Act (Arzneimittelgesetz) and the Act on Advertising for Healthcare Products (Heilmittelwerbegesetz). The law is titled “Viertes Gesetz zur Änderung arzneimittelrechtlicher und anderer Vorschriften“. The draft was deliberated in the health committee of the Federal Council (Bundesrat) on … Continue Reading

EMA Publishes Proactive Disclosure Guidance

On 2 March 2016, the European Medicines Agency (EMA) published guidance on aspects of the Agency’s proactive disclosure policy for clinical reports (Policy 0070).  The latest Proactive Disclosure Guidance can be found here and focuses on: Procedural aspects of submitting clinical reports. The anonymisation of clinical reports. The identification and redaction of commercially confidential information … Continue Reading

Comprehensive Amendments of German Drug Laws upcoming

Recently, the German Federal Ministry of Health published a new draft law (“Viertes AMG-Änderungsgesetz”) which aims to amend several provisions of the German Drug Act (Arzneimittelgesetz) and other drug-related laws. Most of the intended amendments result from an adjustment of German laws to the new European Clinical Trials Regulation (Regulation (EU) No. 536/2014). For instance, … Continue Reading

Spain: Proposed New Legislation on Clinical Trials

The Spanish Ministry of Health has published a draft Royal Decree on Clinical Trials, which the Spanish government is expected to adopt by the end of this year.  Once adopted, the new Royal Decree will replace Royal Decree 223/2004 on Clinical Trials and will regulate all clinical trials with medicines and medical devices in Spain. … Continue Reading

New Rules for Clinical Trials Proposed in Europe

Originally published as Covington E-Alert on August 1st, 2012 On 17 July, the European Commission released the long-awaited proposal for a Regulation on clinical trials on medicinal products for human use (the Proposal). The future regulation will replace the Clinical Trials Directive 2001/20/EC, the revision of which has been advocated by the pharmaceutical industry, academia, … Continue Reading
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