Posted 15 August 2019 | By
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK Confirms US Sites Can Batch Test Drugs in Event of a No-Deal Brexit
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed it will accept results from batch testing performed in the United States in the event of a no-deal Brexit.
MHRA published the original list of countries authorized to perform batch testing weeks before the UK was due to leave the European Union in March. At that time, MHRA said no batch testing done in the US would be accepted after Brexit because such work was outside the scope of the mutual recognition agreement between America and EU until the assessment of member state equivalence was finished.
The March guidance