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Party Bus

Regulatory approval across borders remain suboptimal. The suboptimal description is subjective, and our world has no way to measure optimal international regulatory efficiency. For all the work we have placed in international alignment, in every industry, we have yet to formalize evaluation measures on how we're doing. 

International regulatory alignment is a fun party bus, yet many countries are reluctant to join. If we really trust one another, and our collegial backstory, we know we can join safely. Bus rides can perform stops, breaks when necessary, and rejoining when ready, but they can't wait forever for one to initially hop on. We don't have the option to join at any time, yet after we join, every option is available to us. A country that gets on the party bus remains in control alongside one another. This is especially important as we work toward better medicine for loved ones, for those seeing stars, and for everyone in the world.  


  • Evaluate international regulatory work in a consistent way. Major global governance should initiate a working document that evaluates international efficiency and collegiality to regulatory industry. It could have open, basic descriptions for applicability across industries. Even a seven item instrument would be a great start, such as: regulatory agency liaison inclusion, regulatory policy crosswalk and comparison completion, time it takes for international consensus, conservative or barrier ranking by country, minimum criteria defined for regulatory approval, performance improvement identified for approval times, low and middle income country (LMIC) inclusion and consideration by high income country
  • Prioritize international regulatory bodies and have a path to accelerated process review. In the case of COVID, WHO concerns over LMIC and Emergency Use Listing work should be advanced to ICMRA for review. ICMRA should tap liaisons in countries where assistance is needed. This should be a standard process, accountable to performance evaluations. 

The next pandemic or outbreak should realize the benefits not only from our after action and table top reports; the next pandemic should realize benefits from our commitment to international regulatory alignment performance improvement. 

We don't have the option to join the international regulatory party bus forever. If we join, every option is available to us for the rest of the ride. A country that gets on the party bus remains in control alongside one another. This is especially important as we work toward better medicine for loved ones, for those seeing stars, and for everyone in the world. Get on the international regulatory party bus, and keep optimal alignment a performance improvement end game.   

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