28 December 2016 - Authored by:Birgit Kramer
Regulation (EU) No. 536/2014 on clinical trials with pharmaceuticals for human use (EU Regulation) establishes by directly applicable law binding requirements throughout the European Union (EU) for the approval, the conduct and the monitoring of clinical trials. This made adjustments to the German Medicinal Products Act and the abolition of the German GCP Regulation necessary. The German Federal Government had submitted an according draft for a Fourth Act amending Medicinal Law and other Regulations of 6 April 2016. This draft has been adopted by the Federal Parliament on 11 November 2016 (BT-Drs. 18/8034 of 6 April 2016 with modifications by BT-Drs. 18/10056 of 19 October 2016 and BT-Drs. 18/10280 of 9 November 2016). The Amendment Act was announced in the Federal Gazette on 20 December 2016 and entered into force on 24 December 2016.
With the Amendment Act, regulations in the German Medicinal Products Act that are covered by the EU Regulation will be removed for reasons of legal clarity. In order to regulate competencies and national procedures within the framework of the EU procedures provided for by the EU Regulation, the accordingly necessary provisions will be modified/included in the German Medicinal Products Act. The discretion on a national level provided for in the EU Regulation, in particular concerning the cooperation of the Federal Authorities and the public-law Ethics Commissions of the Federal States will be considered. Specific rules of protection for persons that are concerned by clinical trials, in particular minors, and specific regulations for genetically modified organisms will be upheld. The approval of clinical trials on a national level shall aim at effective and legally certain approval procedure, as high quality clinical trials ensure a swift accessibility to innovative pharmaceuticals.
The German GCP Regulation that implemented GCP Directive 2001/20/EG of 4 April 2001 (that was repealed by the EU Regulation) was abolished.
Further amendments of related regulations concern for example the instruction of the competent Federal Authorities to ensure the completion in the case of adverse events for biological medicinal products by tracking incomplete notifications, the direct transfer of data concerning wholesale permits and GDP-certificates from the authorities of the Federal States to EMA and the clarification that exemption rules in the Act on Medicinal Products also apply in cases of contributions to international aid in the field of civil defence and disaster control.