Covid-19: Regulatory response to the public health crisis
The Covid-19 crisis asks for efficient and timely regulatory responses from relevant stakeholders.
There is a great need for efficacious/safe vaccines and medicines. Regulatory strategies, both from developers, sponsors and authorities, should be designed and tailored to catalyse R&D, speed up regulatory processes and avoid unnecessary bureaucracy. But at the same moment patient safety and public health should be ensured. Finding the right balance in case of a serious and life-threatening emergency like Covid-19 is balancing on a thin rope.
But probably more necessary than ever before.
This regulatory balancing act is at the heart of the ambition of the Regulatory Science Network Netherlands (RSNN). Many members of the RSNN, in a variety of capacities, are involved in shaping an appropriate and informed regulatory response. Addressing emerging health threats is also on the agenda of the EMA Regulatory Science agenda, and more specific, EMA has a dedicated spot on their website for guidance on Covid-19. Other national authorities (e.g. MEB, CCMO, IGJ) have done the same.
Apart from developing vaccines and medicines against Covid-19, this crisis also brings other regulatory challenges. What about ongoing or planned non-Covid-19 clinical trials? All over the world, hospitals and staff have to prioritise critical care of Covid-19 cases over less pressing medical issues. There are also worrying reports on drug shortages, present and expected, with pertinent questions for regulators on how to respond and manage. Globalization of production of essential products and active substances goes with many challenges. The same holds true for unjustified claims of benefits or safety concerns related to certain products in the context of Covid-19. Regulators are there to ensure public health and evidence finding and to reach out to the communities.
The RSNN is engaging actively with stakeholders in addressing the question how efficient regulation can be achieved in a time of public crisis where decisiveness, speed and balanced weighing of the benefit-risk of measures and products are essential.
If you have any observations, experiences or initiatives to share, don’t hesitate to approach us through info@rsnn.nl.
https://english.ccmo.nl/about-the-ccmo/information-ccmo-due-to-coronavirus-outbreak