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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.

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Regulatory Approval of TDF/FTC Boosts Namibia’s Campaign to end the HIV Epidemic

The approval of TDF/FTC (trade name Truvada®) by the Namibian Medicines Regulatory Council (NMRC) on May 11, 2017, brings renewed hope for achieving an AIDS-free generation in Namibia. The availability and use of TDF/FTC for pre-exposure prophylaxis (PrEP) for adults at high risk of sexually acquired HIV-1 in Namibia could significantly reduce the emergence of […]

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Pharmadex Launched in Bangladesh

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 ( 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 […]

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Technical Brief: Implementing a Computerized Medicine Registration System in Mozambique

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.


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Pharmadex launches in Mozambique, streamlining medicines registration

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 […]

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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 in Building Local Expertise for Preventing Antimicrobial Resistance
  • First Class of Pharmacists Graduates from the SIAPS-supported School of Pharmacy in Namibia
  • Inaugural Pharmacist Assistant Forum: A New Platform for Disseminating Pharmaceutical Services Information for Decision-making in Namibia
  • Effective Global Fund Grant Management for Improved HIV/AIDS Service Delivery
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Rapid Assessment of the Capacity of Drug Testing Laboratory of the DGDA of Bangladesh

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 to changing the DGDA’s process, SIAPS conducted a rapid assessment of the DTL’s capacity to conduct pre-approval sample testing in August 2014. The objectives of the assessment were to:
-Review the current pre-approval sample testing process and discuss how to incorporate the functionality of sampling test communication into PharmaDex
-Identify opportunities to improve the pre-approval sampling process to ensure the quality of the products before they reach the market
-Identify any weaknesses and potential disadvantages of changing the pre-approval sampling test process
-Provide initial data to support future technical assistance to build the capacity of the DTL

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Training the Mozambican Pharmacy Department on the Use of Pharmadex

SIAPS was asked in 2013 to review the information system and related technical assistance needs of the Mozambican PD for product registration, licensing and inspection, pharmacovigilance, and quality assurance. In addition, a system analysis was performed to define data elements and identify an appropriate tool that is compatible with local technology and capacity. Based on the needs of the Mozambican PD, Pharmadex was chosen as the most appropriate electronic tool for the management of Mozambique’s regulatory systems information.

The goal of the training was to implement Pharmadex in the PD with the aim of ensuring that the department had the necessary skills, knowledge, and technical support to effectively use and sustain it. Implementation involved adapting the tool to agreed-upon data elements, procuring the required hardware and/or software, identifying in-country IT support and maintenance, installing the program(s), finalizing the software, training users, and preparing for launch of the system.

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February 2014 SIAPS/SCMS/BLC Newsletter

To learn more about what SIAPS, BLC and SCMS are doing in Namibia, you can read all about it here in the January-February 2014 newsletter. Topics include: the impact of  facility level behavioral practices on CMS performance in the supply of ARVs:  a competency framework to inform public health supply chain workforce planning in  Namibia; Namibia’s Pharmaceutical Regulatory Capacity; leveraging technology for more efficient regulation of ARVs and other pharmaceuticals in Namibia; and institutional support for training pharmacist assistants.

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