Spring Intro 2023

30/03/2023

How ? Rest of World – Key considerations

Local clinical study data/ involvement in a global trial data: • Regulatory requirements for local country specific or regional clinical trial data to support filing (including) China, Korea, Taiwan, India, Vietnam, Philippines, Russia, Mexico, Nigeria) Additional/ enhanced stability data • EU/US data package (Zone II) may be accepted in some ROW Markets but also need to consider hotter/more humid countries • Real time data often required to support the proposed shelf life (Typically 12 months real time data plus 6 months accelerated with 3 batches of product) Less flexibility on registered Manufacturing information/ supply chain • Some countries are only able to register 1 manufacturing and 1 packaging site i.e. they cannot 'dual source‘ • Stability data is site specific These and multiple other factors (commercial preference, reference pricing, supply availability etc.) define filing and launch order

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Who ?

Internal • Regulatory (US, EU and RoW) and CMC • Regulatory Affiliates (and Distributors) • Clinical Research and Clinical Operations • Commercial • Market Access/ Pricing-Reimbursement teams External • Regulatory Authorities • Scientific Advice • Regulatory Guidelines • Regulatory Requirements • Distributors

Top Tip: Your Global Lead may not be best placed to advise on Ex-US/EU Strategy There is SIGNIFICANT REGULATORY COMPLEXITY

Seek informed input

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