Module 1 2021

25/06/2021

ASEAN Harmonization

Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam • ASEAN Economic Integration by Dec 2015 established. • ASEAN Common Technical Document Implementation in January 2015. All pharmaceutical submissions should be in ACTD format. • ASEAN Adoption of ICH guidelines on Safety & Efficacy in 2014. RMP & PSUR required. • Discussion and efforts ongoing – RA Capacity Building, Biological/Biotech guideline, MRA on Bioequivalence, GMP inspections, ASEAN Variation Guidelines, PICs certification, ASEAN Joint assessment of MAA of at least 3 ASEAN countries to build technical capacity and mutual trust among regulators.

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Latin America Market Overview

LA market historically constituted 5-7% of the global market

Mexico

Venezuela

Clinical research mostly established and centered in Mexico, Argentina and Brazil, with Chile, Colombia and Peru rapidly evolving.

Colombia

Brazil

Peru

LA expected to grow at 9.3% 2018-2028.

Chile

Argentina

Strong market growth anticipated in Brazil, Argentina, Mexico and Colombia. Brazil accounts for 35% of the LA pharma market.

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