Module 1 2021

25/06/2021

Considerations for Regulatory Strategic Development in Emerging Markets

Regulatory requirements  Clinical Development  File format and content  Label  Source /GMP / Inspections  CPP  Samples  Clinical trials

Other key considerations

● Medical practice/epidemiology ● Medical/commercial need ● Cost/logistics ● Intellectual Property Protection ● Capacity and capability ● Local/generic vs R&D/MNC

 Life cycle  TIMINGS

● Language and culture ● Caution/conservative ● TIMINGS

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General differences ICH and Emerging Markets ICH Emerging Requirements, process timelines reasonably clearly defined in accessible regulations, guidelines Requirements, process, timelines not always available or transparent

Access to regulators variable and often more flexibility of advice. Pre-NDA or development advice needs to be carefully considered Technical requirements more based on ICH than before; some differences in requirements for “local” products CPP often required/requested: adds to timelines and complexity Timelines often unclear and resource often hinders adherence

Access to regulators who can usually give definitive guidance

Technical requirements based on ICH requirements and CTD CPP not required; review based on technical data Timelines communicated, targeted and reported Progress and outcome clearly defined and communicated

Intense follow-up often necessary

Little formal harmonisation – but flexibility is there if sought

Harmonised within EU

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