The European Commission has published a communication to prepare for the end of the transition period. There are also indications for the pharmaceutical sector.
Several European pharmaceutical associations are calling on the EU to give priority to access to medicines in the ongoing Brexit negotiations. Specifically, they are calling for an MRA.
After a 15-month prison sentence, the owner of Immuno Biotech is now threatened with the seizure of GBP 1.4 million in connection with the manufacture, sale and supply of an unlicensed drug.
EMA, EC and HMA have created a Q&A document on regulatory expectations during the covid-19 pandemic. New questions and answers are dealing with remote audits and remote release.
The UK MHRA has published a Guidance for exceptional GMP flexibilities for medicines imported from third countries during the coronavirus (COVID-19) outbreak. This additional flexibility might sound reasonable but it will put a lot of additional responsibility on the QPs.
Due to the current Sars-CoV-2 outbreak, more and more people started working from home; this includes Qualified Persons (QPs). But what do the regulators say when it comes to batch certification?
Because of the Corona crisis, the fact that an auditor has to visit a site currently presents a potential risk to all persons involved or might simply not be possible because of travel bans. What are the options now?
