Implementation of EU directive 536/2014: Ethic committees prepare for the next level

Posted by Dr. Grit Andersen on Feb 7, 2018 4:40:00 PM

Some decisive steps were taken in Germany towards the implementation of the above-mentioned regulation, especially with regard to the work of the Ethic Committees. The regulation about the evaluation of clinical trials [Verordnung über das Verfahren zur Zusammenarbeit der Bundesoberbehörden und der registrierten Ethik-Kommissionen bei der Bewertung von Anträgen auf Genehmigung von klinischen Prüfungen mit Humanarzneimitteln (Klinische Prüfung- Bewertungsverfahren-Verordnung – (KPBV)], published in July 2017, contains some very specific requirements for Ethic Committees participating within the “Directive working frame”.


BfArM, the Federal Institute for Drugs and Medical Devices, published a list of participating Ethics Committees according to §41a of the German Drug Law dated November 10, 2017 on November 22, 2017 in the Bundesanzeiger.

Only public Ethic Committees of the Federal States who are responsible according to federal law for the evaluation of clinical trials in humans were allowed to participate in the registration process. 36 of the existing 53 Ethic Committees have gone through this process and got the approval by the Competent Authorities in Germany (BfArM and Paul-Ehrlich-Institute (PEI)) to assess clinical trials according to the EU-Directive 536/2014.

Furthermore, according to the new regulations, the Ethics Committees have to publish a so-called “Geschäftsverteilungsplan” (distribution-of-business-plan) at the beginning of each year, starting the 1st of January 2018. This plan has to be updated on an annual basis. The plan defines the chronological order of the Ethic Committee being responsible to work on a specific application for an approval of a clinical trial; the plan is taking into account the total number of registered Ethic Committees as well as the individual annual capacity of the respective Ethic Committee. BfArM has already published the first plan.

The entry into force of the EU Directive 536/2014 still depends on the functionality of the EU Portal; the announcement of its functionality has been foreseen for 2019, but even 2020 has been mentioned already. Therefore the distribution-of-business-plan is not yet applicable to the current submissions.

In conclusion, the implementation of EU 536/2014 will lead to a further professionalization of the work of the ethical committees. The implementation of this work plan will hopefully lead to quicker turn-around times. However, some ethical committees might see types of applications that they have not seen often yet.

In a previous blog post I have also talked about some consequences of the Brexit, such as the decision to find a new location for EMA headquarters. On 20th of November 2017, it has been decided that the Netherlands, more specifically Amsterdam, will host the new EMA headquarters. Amsterdam has been chosen among 19 cities that applied for the relocation of EMA. After three cities qualifying for the “finals” (Milan, Copenhagen and Amsterdam), at the end ‘head or tails’ decided between Milan and Amsterdam. The Agency started to work with the Dutch government to ensure the move to Amsterdam by the end of March 2019.

At the moment around 900 staff members are working in London and many of them are willing to move to Amsterdam. Amsterdam met a lot of the requirements set by the EU commission; especially it offers the requested connectivity and a building that can be adapted to the EMA’s needs very fast.

Topics: Clinical Trials in Diabetes