Position paper 6 December 2023

Industry perspectives on implementation of Quality Overall Summary-Product Dossier (QOS-PD) and Quality Information Summary (QIS) for innovative medicinal products

Continuous product supply of quality-assured, safe and effective medicines is in the best interest of patients, regulators and industry. During the COVID-19 pandemic, harmonization of regulatory requirements has proven to increase efficiency in the registration process. While especially important for marketing applications and renewals, harmonized requirements should also apply to documentation for lifecycle management activities. 

Due to the growing complexity of product lifecycle management, all stakeholders need to work together to harmonize regulatory requirements. This will facilitate efficient regulatory review and approval to support timely implementation of changes and product improvements, leading to more resilient supply chains.

In many African countries, supplementary technical quality templates such as the Quality Overall Summary-Product Dossier (QOS-PD) and a Quality Information Summary (QIS) are being implemented as regional or national requirements with the submission of reliance and non-reliance marketing authorization applications. 

In this paper, we outline how additional QIS and QOS-PD documents for innovative product applications, renewals and variations duplicates information that is already available at international level through the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

In order to reduce duplication and provide value adding data to registration processes, in line with the principles of clarity and efficiency, industry puts forward several recommendations.


Position paper pdf | 137KB