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An opportunity we shouldn't refuse

The current pandemic provides an opportunity offer we shouldn't refuse. Global alignment in regulatory processes for medicines has been slow. We should put funding and resources into refining the processes now, for the coming years of COVID management and for the next pandemic, outbreak or global emergency. 

It is refreshing to see WHO and ICMRA step up to the plate. They need unified support and resource-intensive investment, however. 

The world should examine WHO/ICMRA joint priorities, invest in labor for ICMRA and industry liaisons, and request polished organization. 


Priorities around well-designed clinical trials, endpoint and safety data strategies, sharing data for multi-country approvals, incorporating ICMRA regulatory agility in policies and protocols, supporting rapid response for global emergencies, transparency of trial results, strengthening public trust in vaccines, supporting the mitigation and prevention of drug shortages, COVID therapeutic surveillance, addressing safety and efficacy of COVID vaccines and medicines together, and reducing false and fraudulent therapeutic messaging are all achievable. Designing the effort for sustainability and ongoing process improvement in regulatory medicine requires resources. 


* Technological support should be funded based on identified need

* Flexibility for national autonomy should be documented and tracked, for process improvement worldwide

* Criterion by country should be transparent

* Clinical trial consensus should be immediately requested, there has been tremendous work around clinical trial improvements already

* Liaisons with government regulatory, pharmaceutical companies, research institutions and global governance should be funded

* Professional public messaging and communication should be funded 

* Formal strategic planning should be requested, with annual measures and reporting


The world should respect a tremendous effort by recognizing the tremendous opportunity we have. 

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