While momentum is growing in Latin America for more harmonization around the technical requirements for registering pharmaceuticals, currently there are significant divergences among the countries in the region regarding the expectations for the form and content of CMC submissions.
The majority of submissions in Central and South America require information included in the ICH common technical document (CTD). However, the CTD has not been formally adopted in the region, and the country-specific product requirements make registering new drug products in multiple countries challenging.
The CMC documentation and formatting requirements vary considerably regarding, for example: ● raw data ● batch records ● chromatograms ● dissolution profiles, and ● certificates of analysis for drug product samples.
In addition to the divergent filing requirements, expectations for good distribution practices also vary in Latin America (IPQ “In the News” April 19). Especially problematic for international pharma is the shipment of temperature-sensitive products into the various countries in accordance with differing national laws and guidance (IPQ “In the News May 6).
Harmonization efforts are continuing in the region to tackle the disparity in national requirements for product registration.
The World Health Organization’s Latin American regional office – the Pan American Health Organization (PAHO) – has been working with health agencies and industry to find solutions to the registration disparities. PAHO is making inroads on harmonizing dossiers through its 14-year-old Pan American Network for Drug Regulatory Harmonization initiative. PANDRH is working on a guideline that will facilitate use of the CTD format.
[An analysis of the differences in the CMC expectations across Latin America and the efforts to resolve them are provided for subscribers here. Nonsubscribers can purchase the full story for $195 by contacting Jonathan Trethowan (Jonathan@ipq.org). For subscription/license information, click here.]
