CIRS RD Briefing 51 – Submission lag time in the emerging markets
Lag Time (the time from which a product has been granted market authorisation in its first market to the time that its application is submitted for review by an [...]
CIRS RD Briefing 51 – New drug approvals in ICH countries 2002-2011
In 2011, the number of New Active Substances (NASs) approved in all the ICH countries increased compared to 2010, and FDA represented the largest number of new medicines approved [...]
Salek et al 2012 – Scorecards to Assess the Quality of a Regulatory Submission and Its Review
An efficient review depends not only on timely approval but also on ensuring the quality of the process from construction of the dossier to the ultimate regulatory decision. Two [...]
Liberti et al 2010 – Progress on the development of a benefit-risk framework for evaluating medicines
CIRS authors write about benefit-risk in the March 2010 issue of Regulatory Focus by the Regulatory Affairs Professionals Society (RAPS). Article reproduced with the permission of RAPS. Download [...]
Hirako et al 2007 – Comparison of the drug review process at five international regulatory agencies
Regulatory approval time is a key metric that is used to evaluate the performance of regulatory agencies. A new methodology has been developed to compare the regulatory review process [...]
CIRS RD Briefing 46: Building quality into regulatory activities
The Institute for Regulatory Science is currently involved in several activities related to quality as it applies to regulatory submissions and procedures, rather than the more conventional association with [...]
CIRS RD Briefing 50 – Cross-regional comparison of regulatory environment in emerging markets
The emerging markets of Asia-Pacific, the Middle East, Africa and Latin America are becoming increasingly important to pharmaceutical companies in their global strategies for the registration of new medicines [...]
CIRS RD Briefing 49 – Accessing the regulatory environment – Latin America
The Regulatory Agencies in Latin America share a common goal with the research-based pharmaceutical companies that they regulate. This is to ensure that new medicines become available to patients [...]
CIRS RD Briefing 48 – Assessing the regulatory environment – Middle East and Africa
The regulatory agencies in the Middle East and African region that were included in this study share a common goal with the research-based pharmaceutical companies that they regulate. This [...]
CIRS RD Briefing 47 – Accessing the regulatory environment – SE Asia and Western Pacific
The regulatory agencies in South East Asia and the Western Pacific share a common goal with the research-based pharmaceutical companies that they regulate. This is to ensure that new [...]