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Expedited Regulatory Pathways – possible in developing countries with strong reliance practices and post-authorization surveillance systems
Delayed access cost lives. Many low- and middle-income countries lack the regulatory tools for timely access to medical products for unmet public health needs. The current COVID-19 pandemic has shown that it is important to have available regulatory flexibilities to authorize new medical products for use and rapidly manufactured them at scale. Expedited regulatory pathways (ERP) can help countries to accelerate the approval and access to new medical products with positive benefit-risk balance. To best meet those objectives of ERP, developing countries require strong reliance practices and post-authorization surveillance systems as pre-requisite for the timely introduction and safe use of new medical products for unmet public health needs and health emergencies.
1) How regulatory flexibility in low and middle- income countries makes it possible to get expedited drug approvals
2) Why post- authorization surveillance is necessary to enable safe introduction of drugs approved by expedited pathway
- Mathew Cherian, PhD Consultant, FIP Member, Executive Committee, Industrial Pharmacy Section, USA
- Maria Mantziri, Associate ExCo Member, IPS Webinars, Greece
- Jude Nwokike, Vice- President US Pharmacopeia, USA