The coronavirus has had an enormous impact on European regulatory activity. To ease the strain and maintain vital supplies, the European Commission, European Medicines Agency, and Heads of Medicines Agencies published updated guidance in April, including new flexibility and simplified and accelerated authorisation procedures. Here, Monia Nica, senior regulatory affairs manager at Arriello, summarises the new allowances.
Masks
Potential threats to essential product supply due to Covid-19, and challenges managing the usual regulatory administration processes, have caused agencies across Europe to joined forces to determine how best to maintain continuity of drug availability. The result is a new set of guidelines for the exceptional circumstances triggered by the pandemic, published in April and last updated in July by the European Commission (EC), in collaboration with the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), and the European Medicines Agency (EMA).
It is important that marketing authorisation holders (MAHs) are aware of all the amended requirements, so that they do not leave themselves open to gaps or delays in supply. So what’s changed?