SIAPS helped improve pharmaceutical product quality by building the capacity of the Namibia Medicines Regulatory Council (NMRC) to review medicine registration dossiers; inspect pharmaceutical manufacturing facilities and finished (imported) products at ports of entry and in the marketplace; to chemically test medicines compliance with established standards; and monitor overall compliance with applicable regulatory standards and … Read more
In November 2016, at the request of USAID/Benin, SIAPS conducted a rapid assessment of the medicines registration system of the Direction de la Pharmacie, du Médicament et des Explorations Diagnostiques (DPMED) in Benin and made recommendations to address the challenges arising from its current information system. The assessment identified opportunities to improve regulatory processes for … Read more
The introduction of Pharmadex has so far targeted individual country requirements. Currently, under the African Medicines Regulatory Harmonization initiatives, efforts are underway to adopt common and harmonized processes and communication platforms for medicine registration in regional economic communities, such as EAC, ECOWAS, and the Southern African Development Community. The purpose of this report is therefore … Read more
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
In a major advance against the spread of HIV, Namibia has approved the use of emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) to prevent HIV infection. The Namibian Medicines Regulatory Council (NMRC) approved a generic version of the medicine, Ricovir EM®, which is manufactured by Mylan Pharmaceuticals. It is used in combination with other antiretroviral medications to treat … Read more
On May 17, 2017, the Honorable Minister Mohammad Nasim, Member of Parliament (MP), Ministry of Health and Family Welfare (MOHFW), officially launched Pharmadex in Bangladesh. Pharamdex (http://pharmadexbd.org/) is a web-based integrated information system that facilitates the submission, review, and evaluation of medicine registration applications and dossiers on the basis of international standards and formats. Minister … Read more
In 2012, the Government of Mozambique began a national accelerated response to HIV and AIDS. As a result, better awareness, funding, and deployment of proven interventions have significantly improved HIV prevention, treatment, and care support. This includes the rapid scaling up of antiretroviral therapy. With significant support from the US President’s Emergency Plan for AIDS … Read more
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
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
The SIAPS team visited the DTL to assess the DGDA’s readiness for the implementation of the medicine registration process change. The team assessed the process of requesting the reporting pre-approval sample test and discussed how to incorporate the functionality of internal communication on pre-approval sample test into the PharmaDex system. To understand the current challenges … Read more
