COVID-19: The NIPN’s Regulatory and Data Protection Guidance on adjustments in clinical trials

By Bettina Kovecses, Judit Nagy

04-2020

On the tails of the EMA’s Guidance on the Management of Clinical Trials during the COVID-19 pandemic, the Hungarian National Institute of Pharmacy and Nutrition (NIPN) has issued its guidance on how local regulations are to be applied to mitigate the negative effects of the COVID-19 pandemic on the continuity of clinical trials. It also provides divergence from general rules for clinical trials relating to COVID-19.

The NIPN points out that in the course of any decision making and risk assessment relating to adjustments to clinical trials and protocols, the provisions of the ICH GCP, the applicable European and Hungarian legal provisions, including in particular the GPDR, must be observed.

The guidance touches upon general regulatory aspects, as well as data protection issues. Below we highlight some of the key adjustments and safeguards to consider.

Please read the full article on BioTalk here.