- Mots-clés > automated data
- Mots-clés > drug registration
- Mots-clés > harmonization - medicines registration
- Mots-clés > marketing authorization
- Mots-clés > medicines registration
- Mots-clés > medicines registration systems
- Mots-clés > pharmadex - computerized assisted drug registration
- Mots-clés > registration dossier
- Mots-clés > registration of pharmaceuticals
- Mots-clés > Standards Operating Procedures (SOP)
(2016; 33 pages)
Aimiuwu, J. 2016. Improving the Process of Medicines Registration in Bangladesh: Adoption of the Common Technical Document Format and Implementation of Pharmadex to Automate the Registration of Medicines. Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program. Arlington, VA: Management Sciences for Health.
SIAPS has been providing technical assistance to DGDA to improve its regulatory function by helping them adopt international standards for medicine registration based on a common format proposed by the International Council for Harmonization for Technical Requirements for Pharmaceuticals for Human Use (ICH), known as the Common Technical Document (CTD). The use of the format has advantages for both country regulatory authorities and pharmaceutical manufacturers because only one technical data set that is accepted in different countries and regions is generated, thereby reducing the amount of human and animal experimentation. This standardization also provides common regulatory standards for evaluations and inspections and facilitates regulatory communication and information sharing that ensures that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. Furthermore, in the case of Bangladesh, adoption of the CTD may enhance the perception that products manufactured and registered in the country meet the quality and safety standards acceptable for export to other countries, providing faster access to medicines of high public-health value.