The recent COVID-19 pandemic put the health systems worldwide under unprecedented pressure. Global collaboration, on all levels – political, scientific, economical – appears to be paramount in tackling the consequences of “the defining global health crisis of our time”, as the Director-General of the WHO, Dr Tedros Adhanom Ghebreyesus, put it.
The cooperation between health agencies and the pharmaceutical industry plays a crucial role, as the development of vaccines and treatments provides the only means of addressing the root cause of all the consequences the coronavirus outbreak has produced.
In order to enhance access to medicines, health agencies have long sought for alignment and collaboration, the establishment of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) being probably the most prominent initiative to date. However, efforts for closer approximation are ongoing and despite flare-ups of unilateralism in parts of the world, the COVID-19 pandemic might eventually fuel the desire for international collaboration in the development of drugs further.
A recent publication from FDA and EMA representatives provides an excellent overview of the many areas of cooperation between those two leading health agencies. (Tania Teixeira, Sandra L. Kweder, Agnes Saint‐Raymond, Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other? Clin Pharmacol Ther. 2020 Mar; 107(3): 507–513.). According to the authors the most frequently discussed topic between the agencies (apart from “general information sharing”) is “Medicinal Products Applications under review (i.e. NDA/MAA)”.
Based on our experience over the past decades, we have implemented a clear process for simultaneous submissions that allows our clients to take full advantage of the synergies while minimizing the risks of non-compliance or delays. If you consider submitting your applications in two or more jurisdictions within the shortest possible time frame, please contact us today.