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

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.

Latest insights

More Insights
featured image

Employment Litigation in Singapore: Employees Can Double-Strike with Employment Claims Tribunal Win Followed by High Court Claim

4 minutes Jul 11 2025

Read More
featured image

Singapore Issues Advisory to Stop Use of NRIC Numbers for Authentication

3 minutes Jul 11 2025

Read More
featured image

UK Data Protection Reform: Key Updates from the Data (Use & Access) Act

2 minutes Jul 10 2025

Read More