Module 1 2021

25/06/2021

LA: Overall Drug Registration Requirements

Compilation, Translation, Submission ● E-submission: – Chile, Mexico, Central America and Argentina: mandatory. – Brazil (expected) and Colombia – but not mandatory ● Mandatory RA meeting for MAA: Venezuela, Costa Rica

● Pre-submission meeting in Mexico: for new molecules, applicant to present the product to “New Molecules Committee” – RA agreement on strategy, including PVG plan ● Pre-submission meeting is also possible for Argentina and Brazil, to anticipate any discussions with regulatory agency (ANMAT/ANVISA). – In Brazil, pre-submission meetings are mandatory for drugs that treat rare diseases due to the reduced timelines for review Review Process (New MAA) ● Timelines: vary significantly between countries and type of product (more details next section)

– 3 months (Paraguay, Ecuador), 1.5-2 years (Peru), 2-3 years (Venezuela)

Predictability is challenging

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– Mexico: official timelines 6 months (in case of comments, could take 1.5 years to the final resolution) – Brazil has announced measures to determinate timelines for review process (Law 13.411/2016): ordinary molecules: from 6 months to 1 year; prioritized molecules: from 60 -120 days.

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The Organisation for Professionals in Regulatory Affairs

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MEA Market Overview

• > 1.5 billion inhabitants • > 18% of world’s population • Pharmaceutical market ~ US$ 40 Billions • ~ 5% of the world’s market • < 1% of worldwide clinical trials (excluding Israel which is a developed CT market) • Predicted to increase exponentially in next decade.

Arab speaking countries Francophone Africa markets Non-Francophone Africa markets Stand-alone markets

The Organisation for Professionals in Regulatory Affairs

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