Module 1 2021

25/06/2021

Strategy to consider:

Commercial launch and availability plans ● What is ultimate market for the drug and can the market be realised (including pricing and reimbursement)?

Have all required countries been included in Phase III? ● YES: what is impact on overall timing, scope, cost and how can it be managed and efficiencies realised? ● NO: how to include in a follow-up study/studies? – One protocol, reflecting global phase III and label – Minimal end-points – Maximum country coverage – Common database with Global study/Phase III – Scope for KOL involvement – Integrate with registration and re-imbursement strategy – What other outcome data could be generated from follow-on study/studies?

The Organisation for Professionals in Regulatory Affairs

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Key Aspects of Regulatory Environment: Asia North Asia – Japan, Korea, Taiwan • Highly advanced, sophisticated and actively evolving • Locked into multi-country clinical trial concept in Phase III – broad fit with China strategy

India • Political/DCGI changes and flux complicate predictability • Introduction of Subject Expert Committees in India • IND regulatory timelines have significantly improved • New Drug and Clinical Trial Rules effective 19 March 2019. • Defines the timelines and requirements for clinical trials of both imported or locally manufactured products (90/60d) • Stipulates criteria for clinical waivers and orphan drug • requirements.

• China-Japan-Korea tripartite discussions driving closer understanding of respective systems and requirements • Korea MFDS joined ICH in Nov 2016, and China CFDA joined ICH in July 2017 • New guidances and continued improved early access to regulators can be expected.

The Organisation for Professionals in Regulatory Affairs SEAsia • No harmonisation yet of CTA/IND processes and requirements • Mix of predictable countries (e.g. Malaysia, Singapore) and ones with regular change/challenges (e.g. Indonesia, Vietnam) • Generally manageable requirements and timelines with no firm need for local studies for registration (ex. Vietnam)

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