Module 1 2021

25/06/2021

LA Regulatory Overview

• No regional guidelines or regulations…

● No regional application. ● Substantial efforts towards harmonization (past 15 years): Pan American Health Organization (PAHO) via Pan American Network for Drug Regulatory Harmonization (PANDRH). ● PANDRH releases recommendation – including PVG and pharmacopoeias. ● 6 national reference authorities in the region recognized by PAHO: Argentina, Brazil, Chile, Colombia, Cuba and Mexico. • MAA needs to be planned in line with each country’s requirements – Demanding challenges for pharma companies : ● The same regulation have typically applied to all pharma products. – Recently Brazil, Argentina and Mexico have applied regulations for different drug types (biologics, small molecules, generics, biosimilars, devices, orphan drugs.) ● Brazil is now an ICH member.

– Regulations under review to accept dossiers in the CTD format. – ICH guidelines are accepted as reference for requirements . ● Some recognition now implemented

The Organisation for Professionals in Regulatory Affairs – e.g. El Salvador and Ecuador have a simpler process and shorter timelines if Mexico have approved. – Mexico agreements for pharmaceutical products (except biological) and medical devices with USA, EMA, Japan and Switzerland 33

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LA: Overall Drug Registration Requirements

Dossier: requirements can be met by ICH-CTD, but most countries require substantial local (regional) information, CTD Module 1.

Local infrastructure for filing: ● An entity legally allowed to file a MAA (such as authorization or certification to become a MA holder) must be used. For instance: – Argentina: only a locally authorized lab with licensed pharmacist (local own QC facility and depot) – Brazil: only a locally authorized commercial importer, distributer or manufacturer (local own QC facility and depot) – Mexico: local representative can act as the MAH. Company should be registered with the Regulatory Agency. – Some Central America countries: country native expert with valid Power of attorney is required – Partnering with a local distributor, labs, etc is a viable option. This must be arranged prior to MAA i.e. allow time for due diligence and contract agreements. Contractual considerations must be planned in the event of terminating any agreement where a local entity holds the MA on a company’s behalf.

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The Organisation for Professionals in Regulatory Affairs

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