MHRA to ask UK firms for data on API suppliers as new EU import rules draw nearer
This article was originally published in Scrip
Executive Summary
The UK regulatory body, the MHRA, is planning to ask marketing authorisation holders for information about the active pharmaceutical ingredients (APIs) they import into the UK for manufacture into non-centrally authorised drugs, with a view to minimising the risk of product shortages when new EU rules on API imports come into effect next year.