Regulatory Spotlight - 03
August 9, 2024
Showcasing the latest developments, news and updates from African national medicines regulatory authorities
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In countries with limited resources, registration of medicines can be a slow and lengthy process resulting in patients not having access to medicines in a timely manner. These medicines may, however, already be registered by stringent regulatory authorities (SRA) or be pre-qualified by the World Health Organization (WHO). WHO therefore created three collaborative registration pathways: CRP for prequalified (PQ) medicines or vaccines (PQ CRP), pilot CRP for in vitro diagnostics (PQ CRP IVDs), and a CRP for medicines approved by stringent regulatory authorities (SRA CRP).
These pathways were created in 2013, 2019 and 2015, respectively. In the past six months, African national medicines regulatory authorities (NRAs) have been added to the CRPs. The additions include Benin and Lesotho in all three pathways, Madagascar and Togo in SRA CRP, and Burkina Faso, Democratic Republic of the Congo, Senegal and Togo in PQ CRP IVDs. Currently, 65 NRAs participate in PQ CRP medicines, 33 NRAs participate in the PQ CRP IVDs, and 59 NRAs and one regional economic community participate in the SRA CRP. Nearly 1,200 product registrations are being facilitated and a CRP pilot for WHO prequalified vector control products is proposed for six countries: Democratic Republic of the Congo, Ghana, Kenya, Nigeria, Rwanda and Tanzania. The lists of participating countries for the initiatives can be found here: PQ CRP medicines, PQ CRP IVDs and SRA CRP.
Swissmedic and WHO conducted an advanced training workshop on 6 – 7 March 2024 in Addis Ababa, Ethiopia. The workshop's aim was to enhance assessors' ability to evaluate inhalation products and expand the cohort of inhalation product assessors with NRAs. Thirty-one senior assessors from 23 NRAs from five of Africa’s regional blocs attended the workshop. The workshop is part of Swissmedic and WHO’s collaborative efforts to strengthen regulatory harmonisation initiatives at regional and continental level in Africa, aligning with the global objective of improving access to quality-assured, safe and efficacious medicines.
WHO has updated the manual for benchmarking and formulation of institutional development plans to provide clear operational guidance on the benchmarking of regulatory systems for medical products and the development of institutional development plans to address areas for improvement. The manual also serves to ensure a proper understanding of the Global Benchmarking Tool (GBT); the processes and principles that govern its use; the expectations of individuals and institutions involved; and the information management systems that underpin the collection, analysis and management of data and the generation of knowledge. This is a critical aspect of WHO’s structured and evidence-based approach to regulatory systems strengthening. Read the WHO Global Benchmarking Tool for evaluation of national regulatory systems manual.
Burundi announced that it has new regulatory texts that entered into force this year. The texts modify the regulatory process for all pharmaceutical and other health products with the addition of the obligation to register medical devices and other health products. The objective of the new texts is to raise awareness and guide stakeholders on the state of medicines regulation in Burundi to clean up the sector for the health of the population. For more information you can contact the NRA by email: info@arema-international.com
Over the past few years, the South African Health Products Regulatory Authority (SAHPRA) has focused on advancing its digital transformation drive. A significant milestone in this endeavour is the rollout of software that will enable core technical teams to manage health product registration application documents, lifecycle documents/updates and provide enhanced reporting and tracking capabilities. In the coming weeks, various activities will be completed by the SAHPRA team, including migration of legacy data and importation of all recent submissions. An administrative freeze period was introduced on 20 March 2024 to allow the NRA to complete the transfer of all applications received post the First Copy Date, and to bring the latest submissions into the work queues. The migration and start of implementation activities will take place between 21 March 2024 and 15 April 2024. Important activities and dates to note are tabulated in this communication to stakeholders.
SAHPRA, South Africa has published ZA-SAHPRA eCTD Specification and Guidance for Module 1 and Regional Information dated 11 March 2024. The document specifies Module 1 and the regional sections 2.3.R/3.2.R of the electronic Common Technical Document (eCTD) for South Africa (“ZA”). eCTD is the preferred format for submission to SAHPRA. eSubmissions will only be accepted by the authority for specified application types. Applicants and marketing authorisation holders are encouraged to refer to the eSubmission specifications for more information on how to create a ZA eSubmission. eSubmissions are planned as a first step to eCTD, and they will only be accepted for a limited period. SAHPRA intends to eventually move all CTD based application types to eCTD. The ZA-SAHPRA eCTD Specification and Guidance for Module 1 and Regional Information should be read in conjunction with the ICH eCTD Specification to prepare a valid eCTD submission for South Africa.
The Egyptian regulator has indicated the addition of safety warnings to appropriate sections of product information for products such as iron dextran, clopidogrel, tadalafil, leukotriene inhibitors, atypical antipsychotic drugs, valproate sodium and diclofenac topical gel. This is due to the risk levels of different products identified in post market surveillance activities in the country. New applicants and marketing authorisation holders are therefore advised to review the updated pharmacology warnings and to incorporate them as appropriate in product information updates.
Somalia deposited its ratification instrument of the Treaty of Accession to the East African Community (EAC) on 4 March 2024 in Arusha, Tanzania. The country became the regional bloc’s eighth partner state. The other seven partners are Burundi, the Democratic Republic of Congo, Kenya, Rwanda, South Sudan, Uganda and Tanzania. The EAC has the oldest medicines regulatory harmonisation initiative in Africa, and it facilitates access to safe, efficacious and quality essential medical products for treatment, management and diagnosis of conditions of public health importance. The programme does this through harmonisation of regulatory requirements, guidelines, standards and tools for NRAs in the EAC. Among other benefits of EAC membership, Somalia is expected to benefit from the regional regulatory harmonisation initiative.
Rwanda FDA , in partnership with USAID D Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program, conducted a 5-day Good Clinical Practices training in March 2024 for researchers engaged in clinical trials in Rwanda. The training is part of the two institutions’ ongoing efforts to uphold international clinical practice standards, ensure compliance with regulatory requirements and prioritise trial participants’ safety and wellbeing.
The International Medical Device Regulators Forum (IMDRF) recognises that a global approach to auditing and monitoring medical device manufacture could improve safety and oversight internationally. Therefore, IMDRF identified a working group at its inaugural meeting in Singapore in 2012 to develop scientific documents to advance a Medical Device Single Audit Program (MDSAP). MDSAP allows an MDSAP-recognised auditing organisation to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the programme. The Pharmacy and Poisons Board(PPB) of Kenya has become the first African NRA to become an affiliate member of MDSAP; in doing so, it joins Argentina's National Administration of Drugs, Foods and Medical Devices (ANMAT), Ministry of Health Israel, Ministry of Food and Drug Safety of Republic of Korea, the Federal Commission for Protection from Sanitary Risks ( COFEPRIS ) of Mexico, Singapore's Health Sciences Authority ority (HSA), and the Taiwan Food and Drug Administration. International partners in MDSAP include the Therapeutic Goods Administration of Australia (TGA), Brazil’s Agência Nacional de Vigilância Sanitária tária (ANVISA), Health Canada | Santé Canada, @Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency, and the U.S. Food and Drug Administration (USFDA). The European Union (EU), the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA), and the WHO Prequalification of In Vitro Diagnostics (IVDs) Programme are official observers. More information about the MDSAP can be found here.
In an increasingly globalised world, no regulator can exist in isolation. Collaboration and regulatory harmonisation are acknowledged as being critical for NRAs to conduct their regulatory functions. PPB, Kenya has therefore formalised a strategic partnership with the US FDA to facilitate a collaborative framework. The two NRAs signed a Confidentiality Commitment on 15 March 2024 in Washington D.C. This engagement shines a spotlight on PPB’s proactive stance in enhancing regulatory standards and fostering international cooperation. It will also facilitate the exchange of critical information and promote regulatory harmonisation in the medical devices and diagnostics field. Furthermore, this is the first agreement that the USFDA has signed with an African regulator making it a historic moment of mutual trust and confidence building between the two institutions.
The African Union Development Agency-NEPAD(AUDA-NEPAD), European Medicines Agency (EMA), European Commission(EC), and the Belgian Presidency of the Council of the European Union strengthened their support for the African Medicines Agency (AMA) at a high-level event on the European Union (EU) – African Union (AU) partnership on Global Health for equitable access. The EC announced a €10 million contribution, while Belgium contributed €4 million to AUDA-NEPAD for the African Medicines Regulatory Harmonisation (AMRH) initiative to continue advancing the establishment of AMA. This support is part of the Team Europe Initiative on manufacturing and access to vaccines, medicines and health technologies in Africa - European Commission (MAV+). These two contributions complement the EMA’s support to establish the AMA, which is backed by a €10 million EC grant. The AMA is a specialised African Union agency mandated to enhance the capacity of the state parties and regional economic communities to regulate health products and improve access to quality, safe and efficacious health products on the African continent. Twenty-seven African countries have ratified the AMA treaty as of March 2024. The full news announcement can be accessed here.
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