Welcome to the RRPME platform at APLMA. This page provides a summary introduction to the Partnership. It also serves as a platform to share key information and reports on RRPME activities since early 2016.
National Drug Regulatory Authorities (NDRAs) play a vital role in ensuring the availability of safe, effective and quality medicines and medical devices needed to reach the goal of malaria elimination by 2030. For this reason, APLMA facilitates a Regional Regulatory Partnership for Malaria Elimination (RRPME); a multi-stakeholder group comprising of national regulatory authorities, technical agencies, academia, donors, product development partnerships, as well as policy and advocacy specialists. RRPME acts as an overarching platform that links, coordinates and provides accountability and direction for activities aimed at malarial elimination, taking account of and leveraging existing regulatory networks. The RRPME meetings provide regulators and partner organization with the opportunity to review progress, discuss challenges, set priority actions and announce new commitments. The RRPME aims to introduce regulatory pathways in Asia Pacific for expedited approval of and access to quality drugs and medical devices for malaria elimination. If a strong proof of concept is established for new malaria products, it could then be broadened and integrated into regional and national systems, and could be applied for other life-saving health commodities. The RRPME also aims to share best practices and encourage the roll out of mechanisms to monitor substandard and falsified antimalarial commodities and to reduce the circulation of Oral Artemisinin Monotherapies, and aims to also improve access to quality commodities for all by expanding on existing strategies and developing new ways to engage the private sector for service delivery.
The first meeting was held in March 31- April 1, 2016 in Bangkok to explore the establishment of a Regional Regulatory Partnership for Malaria Elimination (RRPME), during which 12 recommendations were agreed upon. These recommendations are detailed in the meeting report of the first RRPME. These recommendations were intended to support one of the six priority action items endorsed by Leaders in 2015 as part of the APLMA Leaders Malaria Elimination Roadmap, namely to ensure the availability and access to high quality malaria services, tests, medicines, nets and insecticides. It was also recognized from the outset that factors beyond the regulation of medical products must also be addressed as part of a comprehensive malaria elimination strategy, including procurement and pricing policies and supply chain issues, as well as the regulation and use of vector control products such as bed nets and insecticides.
The purpose of the second meeting of the RRPME, hosted by the Government of Indonesia and held on 14-15 December 2016 in Jakarta, was to formalize the partnership and to initiate a plan of regulatory support to priority countries, guided by an overarching strategic plan and operating model and informed by the latest intelligence on products of interest and the regulatory needs of the target countries.
Specific objectives of the second RRPME meeting were to:
The Report and all related documents for the Second Regional Regulatory Partnership Meeting, held on December 2016, can be found here.
Five key recommendations were formulated during the meeting, and are detailed in the meeting report. The meeting successfully identified priority medicines and diagnostics for registration in individual countries to support malaria elimination efforts. The recommended next steps include the appointment of country Focal Points. As we prepare for the next meeting, the RRPME is now working in close collaboration with Focal Points to shape country specific workplans to address regulatory bottlenecks and encourage joint product assessments for better access to quality malarial products.
The Third meeting of the Regional Regulatory Partnership for Malaria Elimination (RRPME) was jointly convened with the World Health Organisation (WHO) and took place in Ho Chi Minh City, Viet Nam, between on the 16th and 17th of August 2017. 14 country participants, including representatives from the National Regulatory Authorities and National Malaria Programs of 9 priority countries attended this meeting, alongside representatives from 12 technical and other organisations to the RRPME including the founding partners to the RRPME; the WHO, the Australian Therapeutics Good Administration (TGA), the Duke-NUS Centre of Regulatory Excellence (CoRE) and APLMA.
The objective of the workshop was to validate and prioritize the gaps in regulatory systems which impede on access to priority antimalarial medicines and diagnostics. Preparatory work was undertaken to compile information on these regulatory gaps from the Second RRP meeting and from the WHO assessments of the 9 countries’ regulatory systems. Information from other assessments by CoRE and in-country visits by APLMA and TGA were also taken into consideration for this exercise.
Subsequently, the breakout sessions held during the Third RRP meeting provided the opportunity for both country representatives and technical partners to develop specific capacity development activities that could answer to these regulatory gaps, and support rapid access to and vigilance and surveillance of quality assured antimalarial products. The meeting also offered the possibility to review the available registration mechanisms (such as the ASEAN Joint Assessment Review) and how these could facilitate in-country registration of priority medical products and build capacity.
The meeting led to 9 specific country workplans and a list of common activities for regulatory support through the RRP partners. Since the meeting, these workplans are being finalized and validated at the country level and will guide capacity building activities in the region conducted by and with RRP technical partners between 2018-2020.
Documents and presentations from the meeting can be found here.
The Fourth RRP meeting was hosted by the Ministry of Health Cambodia in Phnom Penh, on the 13th and 14th of June 2018. The partnership is particularly grateful to Her Excellency Dr Or Vandine, Director General for Health Cambodia, Dr Heng Bunkiet from the Department of Drugs and Food, Dr Huy Rekol and Dr Dysoley Lek from the National Center for Parasitology, Entomology and Malaria Control (CNM) for hosting this meeting.
The Fourth RRP meeting gathered participants from six RRP countries including Cambodia, Lao PDR, Indonesia, Thailand, Vietnam and the Philippines1. The objectives of the RRP IV were to report on implementation progress against RRP Workplans since August 2017, to provide an update on the RRP as the regional chapter of the WHO Coalition of Interested Parties (CiP) for Asia-Pacific and to share an update on the pipeline of priority antimalarials and diagnostics.
Participants worked jointly to identify priority activities for 2018 and 2019 in the form of targeted action plans and timelines towards Q4 of 2019, along the three pillars of work: from market authorisation to vigilance and post-market surveillance. The RRP IV also provided useful insights into the outcomes of the TGA’s scoping missions in Myanmar and Lao PDR and Papua New Guinea, to inform the re-design of the DFAT Regulatory Strengthening Program (RSP). The meeting triggered detailed discussions on the timeline for introducing and rolling out new malaria commodities that will be essential to the elimination of the disease in Asia Pacific by 2030. These include, Tafenoquine, G6PD point of care tests and ultra-sensitive Rapid Diagnostic Tests
During session 1, participants highlighted the importance of partnerships to improve regulatory systems in a more cost-effective manner, and the value of cross-border collaboration to address common challenges including the circulation of substandard and falsified medicines. Session 2 allowed for further discussions on Collaborative Registration Processes for both medicines and medical devices and the value of online registration systems to streamline application processes and increase efficiencies within NRAs. Session 3 and 4 introduced new initiatives to improve vigilance and the importance of post-market surveillance and quality control, beyond registration – hence the title of this meeting on access to safe and quality products.
Participants recognised the value in bringing together both NRAs and malaria programs, to highlight the need for new treatments and to jointly discuss priorities for the registration of new technologies, in support of the goal of a malaria free Asia Pacific by 2030.
Documents and presentations from the meeting can be found here.