The New Clinical Trials Regulation EU No 536/2014 - Amendments to the German Drug Law

Posted by Dr. Grit Andersen on Mar 9, 2017 5:02:00 PM


Since the new clinical trial regulation has been adopted on 16 April 2014, Profil has been anticipating the changes to be compliant with the new regulation as soon as necessary.   Through our blog, we have been updating you about the changes on clinical trials, the pilot project in Germany- which allows sponsors to submit clinical trials according the new regulation before it will become applicable (October 2018) - and the challenges Germany is facing due to the implementation of this project.


Among the challenges, we highlighted the requirements on the composition of the Ethics Committees (presence of a biostatistician, gender equality distribution and members with scientific expertise), with special attention to the differences of its compositions based on states’ different legal frameworks, such as a requirement of a pharmacist (North Rhine-Westphalia, Germany) or patient advocates (Rhineland-Palatinate, Germany).

Moreover, we presented the new EU portal and EU database delivery time frame, in which the highlights were:

Auditable version released for audit

July 2017

Audit endorsed by EMA Management board

December 2017

Production version completed

July 2018

Regulation (EU) n 536/2014 becomes applicable

October 2018

Directive on Clinical trials 2001/20/EC no longer applicable

October 2021


The Fourth Amendment of the German Drug Law

The fourth amendment of the AMG (Arzneimittelgesetz), related to the new Clinical Trials Regulation (EU) n 536/2014, was announced on the 23rd of December 2016 in the Federal Law Gazette and came into force on the 24th of December 2016.

As this amendment brought into question new aspects of German compliance within the EU Regulation, on 14 of February 2017 Profil hosted a DGPharmMed meeting to discuss the impact of these changes in clinical trials.

Although some essential changes will not be applicable before the second half of 2018, some parts of the amended law are applicable from now on, specifically articles 1, 2a, 3, 7, 9, 11, 12 and 12a of the publication in the Federal Law Gazette. [1]

Ethics Committees' new registration procedure

One of the important changes already in force is the registration procedure for ethics committees. Participating Ethics Committees that, according to national law, are responsible for the examination and evaluation of clinical trials have to register at the Federal Institute for Drugs and Medical Devices (BfArM) until the 30th of September 2017. Until the 1st of January 2018, the registered Ethics Committees (or a body designated by them) have to enact a common organisational chart for all registered Ethic Committees. This chart has to be updated annually.

The Federal Ministry of Health is in charge of issuing an ordinance, which will contain, among other points, the rules of procedure specifying the details of the Ethics Committees’ registration process. It will also establish the time limits for the Ethics Committees to issue their opinions and the criteria for a business distribution plan. A draft version of this ordinance will be published shortly. In addition, it has the right to establish a Federal Ethics Committee to guarantee the processing of the actions described in the Regulation (EU) No 536/2014, which could lead to further changes in the approval procedure for clinical trial studies within Germany.

After the full implementation of the new process of clinical trial approval, which is planned to take place after the functionality of the EU-Portal has been proved (scheduled for October 2018); we can expect a clear vote for a clinical trial with a respective reasoning, ONE notification from the Competent Authority (BfArM or PEI) for ONE fee taking into account that the notification is an administrative act. In case the applicant doesn’t accept the Competent Authority decision, he will need to appeal to a court and, in this case, the Competent Authority will be the defendant.

New definitions in place

Among the other changes applicable after the second half of 2018, there are new important definitions as for example that a non-interventional study is a clinical study that is not a clinical trial (Article 2, paragraph 2, No. 4 of Dir (EU) No. 536/2014). Other new designations will be in place such as new definitions of Sponsor, Investigator or Principal Investigator. However, no new description is given for the responsible Investigator of a multi-centre trial within a country.


Check out the blog from time to time! We will keep you updated on the progress of this new regulation.

If you want to discuss the topic with us already and see how we can help you comply with the new changes, just schedule an appointment to talk to our expert team.

[1] Article 1 (broad amount of changes in several articles from §10 to §147) ; article 2a (Change to the Pharmacy Act); article 3 (Change to the German Good Manufacturing Regulation) article 7 (Change to pharmacy operations regulations), article 9 (Change to the Apothecaries Act), article 11 (Change to the German Drug Law Civil Defense National derogation) , article 12 (Change to the pharmaceutical-advertising law) and article 12a (Change to the Second Law of pharmaceutical and other amendments) of the Federal Law Gazette.

Topics: Clinical Trials in Diabetes