2015-09-09-世界卫生组织-First_WHO_implementation_workshop_on_regulatory_evaluation_of_biotherapeutics_including_biosimilars_in_the_African_region_17页_201kb

Summary of WHO Implementation Workshop on Regulatory Evaluation of Biotherapeutics and Biosimilars in Africa

The workshop, titled "First WHO Implementation Workshop on Regulatory Evaluation of Biotherapeutics Including Biosimilars in the African Region," was held in Accra, Ghana from September 8-10, 2015. It aimed to advance the implementation of World Health Organization (WHO) guidelines for biotherapeutics (BTPs) and similar biotherapeutic products (SBPs) within African regulatory frameworks. Key participants included regulators from sixteen African countries and representatives from manufacturers' associations.

Key Objectives and Activities

• Implementation of WHO Guidelines: The workshop focused on applying WHO guidelines to regulatory practices in Africa, ensuring alignment with global standards. It explored head-to-head comparability studies for SBPs, emphasizing their importance for quality, safety, and efficacy.
• E-Learning and Capacity Building: An e-learning platform was utilized for pre-workshop preparation, facilitating self-study and interaction. The event highlighted the need for capacity building due to expertise gaps and recommended work sharing among African regulatory authorities (NRAs) as a short-term solution.
• Regulatory Harmonization: Discussions underscored the need for regional harmonization of regulatory approaches for BTPs and SBPs.

Main Discussions and Findings

• Regulatory Expectations: Workshops reviewed key principles from WHO guidelines, including the stepwise evaluation of quality, nonclinical, and clinical data for SBPs. Challenges included misunderstandings in terminology, lack of expertise, and the need for improved pharmacovigilance.
• Case Study on Biosimilar EPO: A case study illustrated quality assessment issues, stressing the importance of comprehensive data for licensing decisions, particularly regarding immunogenicity and clinical equivalence.
• Panel and Closed Session Insights: Regulators shared experiences, identifying needs for better understanding of BTP regulation and proposing collaborative measures like expert pools and joint inspections.

Conclusions and Recommendations

• Immediate Needs: Strengthening expertise through capacity building and clarifying regulatory concepts is crucial.
• Long-Term Strategies: Promote work sharing and regional harmonization to enhance mutual recognition and efficiency in regulatory processes.
• WHO's Role: Facilitate training programs, utilize e-learning platforms, and support NRA capacity to meet international regulatory expectations.

The workshop reinforced the importance of science-based approaches in biosimilar regulation and advocated for continued collaboration to address gaps in African regulatory capacities.