Understanding Swissmedic MAGHP and its Role in Health Product Security in Africa.
Background
Reliable access to safe, effective and quality diagnostics, therapeutics and vaccines is a critical imperative to quality healthcare in any given population. Strong regulatory systems play a key role in ensuring that this is achieved through effective, efficient and transparent regulatory review procedures. This ultimately contributes to economic productivity and stimulates investment anchored on reliability of healthcare systems. In Africa out of 55 African Union (AU) member countries, only six (6) of the National Medicines Regulatory Agencies (NMRAs) have attained Maturity Level 3 (ML3) according to the World Health Organization (WHO) Global Benchmarking Tool (GBT) Assessments conducted. This demonstrates that only these regulatory agencies have reliable regulatory systems to respond to public health Emergencies efficiently without compromising on routine regulatory activities. With Africa accounting for about 25% of the global disease burden, there is a critical need to invest in strategic interventions and programs that ensure reliable access to medical technologies needed to respond to these conditions. According to the Pharmaceutical Manufacturing Plan for Africa (PMPA) 2009, some of the key challenges that were impeding development of Africa’s pharmaceutical industry were: human capacity shortfalls, weak regulatory systems which contribute to influx of counterfeit, substandard & falsified medicines while constraining the development of the sector, weak procurement and supply chain management systems, limited research capacity and financing among others. To address these gaps especially on the regulatory systems strengthening front, it is imperative to explore novel pathways that offer alternative pathways for registration of medicines such as the Swissmedic Marketing Authorization of Global Health Products (MAGHP). In collaboration with Swissmedic we hosted a two (2) part webinar series on “Understanding Swissmedic Marketing Authorization of Global Health Products (MAGHP)” with focus on industry on July 12, 2024, and with focus on national regulatory agencies on July 19, 2024.
The objectives of these industry discussion forums were to:
- Create awareness about the Swissmedic MAGHP Procedure to industry, national regulatory authorities and development partners interest in medicines regulatory procedures in Africa.
- Outline the benefits and requirements for industry to use such a pathway in medicines registration
- Outline the features and process involved in medicines registration through the procedure with focus on how African national medicines regulatory authorities can participate in the program.
Methodology
Considering the burden of infectious diseases and compounding burden of Non-Communicable diseases (NCDs) in Africa, it is imperative to facilitate timely and reliable access to novel therapeutics in the continent. One mechanism of making this a possibility is to draw on expertise and foster strategic engagements to expedite the registration pathway for medicines in the continent. Cognizant of this need, we designed the project in the following format:
- We did cross-sectional literature review to establish the regulatory bottlenecks and opportunities to unlock these possibilities to make therapeutics accessible in the continent. Through this we established that registration timelines serve as a barrier to market entry for industry in the continent. However, it was also evident that interventions were being put in place to address this. These were however not achieving their expected outcomes due to:
- Limited knowledge and understanding of the procedures by industry professionals and other stakeholders who could use them. They were therefore not being considered during regulatory strategy development phase for new product registrations.
- Limited knowledge and openness to these procedures by national medicines regulatory authorities which was making it challenging for industry to adopt the same as the success of the same was not guaranteed
- We further conducted document analysis with focus on case reviews of existing regulatory pathways to establish the available regulatory pathways that could be utilized to reduce registration timelines while driving access to therapeutics in the continent. Through this we reviewed Swissmedic MAGHP, European Union Medicines for All (EUM4all), WHO Prequalification (WHO PQ), Joint Assessment Procedures (JAPs) such as East Africa Community Medicines Regulatory Harmonization (EAC-MRH), WHO Collaborative Registration Procedure (WHO CRP), Regulatory Reliance among others.
- Guided by the above findings we prioritized the procedures for which to facilitate industry discussion forums starting with Swissmedic MAGHP. The criteria for selection were based on companies from the domicile country with innovations of need in Africa, responsiveness of the regulatory officers we approached.
Swissmedic MAGHP Procedure
Scope and Eligibility of Products
The MAGHP aims at accelerating access for products targeting a concrete medical need in endemic regions. The MAGHP focuses on the sub-Saharan region of Africa and on medicines for diseases that disproportionately affect this region, although other countries or regions may also be considered.
Your medicinal product is eligible for the MAGHP in case it is:
- a medicinal product with a new active pharmaceutical ingredient (new API)
- a medicinal product with a known active pharmaceutical ingredient in a new indication
- a medicinal product with a known active pharmaceutical ingredient (known API) There is no strict restriction to certain indications.
The MAGHP is based on the approach of actively involving regional National Regulatory Agencies (NRAs) and the WHO in the Swissmedic assessment process. This helps in building trust and confidence in the process and is expected to facilitate the granting of national marketing authorizations following Swissmedic’s approval. For submission to Swissmedic, a Swiss Marketing Authorization Holder/applicant with the necessary authorizations to act as MA holder is required. Some valid establishments as registered by Swissmedic are listed for verification. Applicants keen to apply through the procedure where they do not fulfil this requirement have the option of hiring a Regulatory Office that meet these requirements.
The procedure consists of two independent – ideally subsequent components:
For Marketing Authorization, there are two tracks:
- Standard Procedure: The procedure follows the regular Swissmedic marketing authorization procedure with the difference that concerned NRAs and the WHO are involved.
- Light Procedure: This special procedure is applicable to all applications in the fast track and temporary authorization procedures.
Overview of MAGHP
The use of SRA Collaborative Registration Procedure is strongly encouraged as a vehicle to facilitate provisions of assessment and inspection reports following the MAGHP. SRA CRP allows for an effective
management of the post-authorization changes and helps increase the outreach of the procedure.
National Regulatory Agencies (NRAs) and World Health Organization (WHO) are involved in the process as follows:
- Information Access:
- They access full documentation as submitted by the applicant (product dossier)
- They have access to Swissmedic assessment reports and List of Questions (LoQ)
- Provision of Input
- They evaluate and write assessment reports
- They add questions to List of Questions (LoQ)
- Participation in Meetings
- They participate in scientific advice/pre-submission meetings
- They can participate in case team meetings & experts review board. These are however internal meetings at Swissmedic.
Note: The choice about the NRAs/WHO to be involved follows the applicant’s request. NRAs/WHO decide about their participation following an invitation based on applicant’s request.
To facilitate/accelerate the decision process, the applicant is encouraged to submit the applications at the involved NRAs / WHO as early as possible.
Cooperation with WHO and complementarity with WHO CRP
There is continuous exchange with the WHO which helps in optimization of synergies. It helps to facilitate the provision of assessment and inspection reports following the MAGHP.
SRA CRP allows for an effective management of post-authorization changes and helps increase outreach of the procedure. For prequalified products, the PQ-CRP should be used
Benefits of Swissmedic MAGHP
The procedure helps building trust and confidence in the process.
- It helps building capacity at the involved NRAs.
- It is expected to facilitate and speed up the granting of national marketing authorizations following Swissmedic’s approval (by “well informed reliance”).
- No restriction to specific indications.
Session 1: Focus on Industry and Development Partners
A total of 81 participants drawn from 18 countries joined the call i.e., Kenya, Nigeria, Rwanda, Cote D’Ivoire, Liberia, Switzerland, Uganda, Ethiopia, Malawi, Zambia, Namibia, France, Netherlands, Tanzania, Cameroon, South Africa, Zimbabwe, Singapore and United Arab Emirates (UAE). The profile of those who enrolled were Regulatory Affairs Professionals, Pharmacists, Pharmaceutical Scientists, Medical Doctors, Clinical Researchers, Program Officers, Product Security Professionals, Quality
Assurance Professionals, Entrepreneurs, Academicians and Students.
Session 2: Focus on National Regulatory Authorities (NRAs)
Total number of participants were 69 drawn from 32 countries as outlined below. The professional backgrounds were: Academicians, Regulatory Affairs Professionals, Regulatory Assessors, entrepreneurs, Programs Officers, Medical Directors, Supply Chain Advisors, Supply Chain Professionals, Health Systems Experts, Qualified Persons for Pharmacovigilance (QPPV), Quality Assurance Managers among others. Countries represented were: Kenya, Australia, Rwanda, Belgium, Burkina Faso, Ethiopia, Eswatini, France, Qatar, South Sudan, United States, Uganda, Malawi, Mozambique, Namibia, Somalia, Burundi, Egypt, Djibouti, Nigeria, Pakistan, Tanzania, Tunisia, Cameroon, Cote D’Ivoire, Liberia, Morocco, South Africa, India, UAE, Zimbabwe and Ghana
Conclusion
With growing interest in novel regulatory pathways geared towards promoting health product security in Africa, it is imperative to drive industry sensitization forums to make these pathways mainstream
procedures. This will help:
- Improve the use of these pathways regulatory agencies
- Promote efficiencies in resource allocation and use especially by regulatory agencies with nascent systems.
- Reduce registration timelines with faster access to innovations for the African people.
- Build capacity of participating national regulatory authorities driving reliability of regulatory systems in the continent.