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.
Model Business Process Flows for Registration of Medicines: A Guide for Establishing a Standardized Generic Version of SIAPS Pharmadex Software
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.
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
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
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.
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.
- Inventory Control and Good Storage Practices Training for Primary Health Care Nurses and Pharmacy Staff in Khomas, Ohangwena, and Otjozondjupa Regions, Namibia
Although SIAPS introduced a number of automated inventory control tools, such as the Facility Electronic Stock Card (FESC) and Electronic […]
- Department of Health Training Guide on Warehousing and Distribution of Family Planning, TB, and other Health Commodities in the Philippines
This guide is written for the DOH Philippines’ LMD. It can be used as support material in the training and […]
- Development of Standard Operating Procedures to Strengthen Demand and Supply Planning of DOH Philippines
In line with the objective of the Department of Health (DOH) to strengthen supply chain management for pharmaceuticals and health […]