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 norms. In addition, SIAPS supported MOHSS in strengthening the management and regulation of medical devices and support equipment in Namibia, and in revising the National Medicines Policy, a crucial of pharmaceutical regulation and governance. SIAPS supported the reconfiguration of the desk-top Pharmadex tool to a web-based application. In general, the six-year support of the SIAPS project to the NMRC contributed to the strengthening of this regulatory agency, which in turn, contributed to improvements in service delivery to the clients. The registration process improved, to decrease the long-standing backlog of dossiers; PMS ensured safety and quality of pharmaceuticals; and implementation of web-based Pharmadex provided a means for clients/applicants to upload applications and follow up the progress of dossier review, which reduced workload for NMRC staff. SIAPS provided continuous TA for the restructuring of the NMRC.
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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 the efficient and transparent registration of medicines. The purpose of SIAPS’s technical assistance visit in August 2017 was to conduct a situational analysis regarding the findings and recommendations made after SIAPS conducted a rapid assessment in November 2016. The goal was also to develop appropriate recommendations and a plan for the implementation of Pharmadex software and the management system of the medicines registration process at DPMED, Benin.
SIAPS final report showcases achievements across 46 countries. Interventions are described by intermediate results and health areas and demonstrate how SIAPS successfully worked with a range of stakeholders, including Ministries of Health, to bolster pharmaceutical systems and address country-specific needs.
Model Business Process Flows for Registration of Medicines: A Guide for Establishing a Standardized Generic Version of SIAPS Pharmadex Software
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 to describe the currently known processes in selected countries and develop a model set of business processes for medicine registration based on internationally accepted standards. These model business processes can then serve as the basis for establishing a model version of Pharmadex’s registration module.
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 prevention of mother-to-child transmission of HIV programs. SPS focused on strengthening systems based on World Health Organization (WHO) building blocks, increasing the number of pharmaceutical personnel available for service delivery, strengthening policy coordination, and improving the regulatory functions of the NMRC. SIAPS focuses on further strengthening of regulatory and management systems in the pharmaceutical sector under the governance and health systems strategic area to support HIV and AIDS and other public health services.
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 […]
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 […]
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 Relief, coverage of eligible adults rose from 47% in 2012 to 72% by the end of 2013 (PEPFAR Mozambique Country Operational Plan, FY14).
However, there is a shortage of quality essential medicines in the country, exacerbated by the time it takes for medicine importers and distributors to get authorization for importing and selling medicines. The longest wait times are for antiretroviral, antimalarial, and new molecule medicines that require more complex documentation, such as World Health Organization (WHO) prequalification. To help close these gaps, Mozambique engaged SIAPS to strengthen the pharmaceutical sector’s institutional and individual capacity.
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 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.
On October 1, the Pharmacy Department within Mozambique’s Ministry of Health successfully launched Pharmadex—a major achievement, and a significant step toward making the country’s medicines registration system more effective and transparent. Pharmadex, a SIAPS-supported web-based tool, supports a more efficient medicines registration process by organizing and housing all relevant information needed for an application to […]
Project dates: 2011-2016
The end use verification (EUV) survey was conducted on December 21-30, 2017, in the departments of Zou and Collines. The […]
Project dates: 2012-2018