SIAPS provided technical assistance to facilitate the expedited assessment and registration of new and existing ARV formulations to support the implementation of the revised Namibian ART guidelines (dated January 2014). The technical assistance focused on improving the efficiency of the regulatory system so that the recommended new first-line fixed-dose combination ARVs that contain tenofovir and … Read more
Archive medicine registration
Strengthening Registration and Quality Assurance Systems for Generic ARVs, Related Medicines, and Devices in Namibia
In Namibia, USAID has been providing funding for technical assistance in the areas of pharmaceutical management and systems strengthening since 2003. During this period, the Rational Pharmaceutical Management Plus (RPM Plus) and Strengthening Pharmaceutical Systems (SPS) programs were implemented. RPM Plus supported interventions that largely focused on strengthening systems for the antiretroviral therapy (ART) and … Read more
Situation Analysis: Regulatory Data Management System of Philippines FDA
The goals of this situation analysis were to evaluate the current status of the PFDA’s overall regulatory information management system, with a focus on medicine registration data management, and to develop recommendations and an action plan to cultivate a more robust regulatory information management system, including the required IT solutions to manage licensing of drug … Read more
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
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 … Read more
April 2015 SIAPS/SCMS/BLC Newsletter
In this issue: Piloting Mobile Phone Messaging Services to Enhance Patient Adherence to Antiretroviral Treatment Information on Antiretroviral and Other Medicines Registered in Namibia Now Available on a Web-based Platform BLC Disburses a Capacity Development Grant to Tonata to Improve Service Delivery by the Network of PLHIV in Namibia Synergy with UNAM’s School of Medicine … Read more