Emerging Markets Programme Research

Emerging Markets Programme Research: Expanding access to medicine

Emerging Markets Regulatory Review Times (EMaRReT) database

The Emerging Markets Regulatory Review Times (EMaRReT) database provides regulatory benchmarking and trend analysis on regulatory approval times for the Emerging Market countries. The goal of the project is to provide an analysis of various factors that impede or accelerate the time it takes companies to deliver a medicine globally. The analysis provides stepping stones for companies to define a regulatory and development strategy plan.

The database draws on existing data, collected since 2004 and updated for submissions and approval to 2009. To date, the database contains 2000 submissions to the Emerging Market countries, made up of 115 new active substances and 173 major line extensions and used for comprehensive analysis, including: dates of first worldwide and Emerging Markets submission/approval; use and submission date of the certificate of pharmaceutical product (CPP), to determine if submission times affect approvals; and product characteristics.  Data are collected for many of the commercially important countries, including the BRICK TM (Brazil, Russia, India, China, South Korea, Turkey and Mexico) countries.

Focus studies

• A series of investigatory surveys, focussing on specific areas of concern within the regulatory environment with data collected directly from both agencies and participating companies. The topics of the studies are determined by the participating companies and data have been collected since 2004
• 2011 Study Plan: The topic of the study will centre on barriers to new medicines’ development and licensing in the Emerging Markets, a topic that will also help inform the annual Workshop

Regulatory agency registration reports

In 2007, CIRS developed agency-specific reports containing details on the agencies’ review models, target timelines for new drug applications and type of assessment models and quality measures and implementations used. The reports will be updated in 2010 to address current and future changes being made by regulatory agencies including changes to the review process and assessment models and methods for building quality into the regulatory process.