AFRICA— The Africa CDC has adopted the new WHO policy, which establishes parallel processes for recommendation guidelines and WHO Prequalification (PQ) or Emergency Use Listing Procedure (EUL) assessments in order to reduce delays and streamline access to important health items.
Previously, the lengthy WHO Prequalification (PQ) procedure had for long been recognized as a serious hindrance to promoting Africa’s local manufacturing goal.
As a result, the long and fragmented regulatory approval processes presented substantial hurdle, causing market access delays and placing financial and administrative obligations on African industries.
This has been a problem since the late 1980s, whereby the World Health Organization (WHO) has been using a stringent safety, quality, and efficacy assurance method known as “WHO Prequalification” (PQ).
This method assures that vaccines, medications, diagnostics, and other health products supplied by procurement agencies meet approved criteria, hence easing regulatory assessment and health product adoption in low-resource settings.
Obtaining WHO prequalification to enter the United Nations (UN) procurement system is especially important for African businesses to obtain the economies of scale required for building a suitable manufacturing ecosystem, including Research & Development.
With this news policy adoption, Africa CDC regard the new WHO guideline as a crucial step toward reducing gaps in the timely access to essential and innovative health products.
This now forms a strategic effort that emphasizes on the importance of local manufacture and access to health items in Africa’s health and security agenda.
The implementation of interim standards, particularly for innovative items, will now speed up processes. However, considerable efforts are required to fulfill high data and evidence standards, comprehend dossier submission criteria, and actively interact with PQ’s consultation processes..
To make this vision a reality, a sustainable vaccine development and manufacturing ecosystem must be established.
his has to be supported by research and development, intellectual property (IP) and technology transfer, strong regulatory systems, innovative and sustainable financing, strategic partnerships, and commitments from African and global procurement agencies to purchase vaccines produced on continent.
African leaders have pledged to increase the proportion of vaccines, medicines, and diagnostics manufactured locally in Africa to 60% by 2040.
Efficient and harmonized regulatory pathways are vital for sustainable manufacturing in Africa.
The acquisition of maturity level 3 (ML3) status in five African countries, along with ongoing competency programs through Regional Centres for Regulatory Excellence (RCOREs), underscores the importance for African regulatory experts to possess expertise and capabilities aligning with adequate regulatory oversight across the entire lifecycle of vaccine production.
Following that adoption, WHO has committed to support the strengthening of these activities and engaging and communicating across diverse stakeholder communities.
Looking ahead, Africa CDC will also monitor the progress and execution of these and similar recommendations for the benefit of local manufacturing of pharmaceutical products in Africa.
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