Jane H. Mashingia's scientific contributions

Publications (4)

Article
Full-text available
Background: For almost a decade, the East African Community has implemented the Medicines Regulatory Harmonization (EAC-MRH) programme among its member states to harmonise technical requirements and standards for medical products regulation, jointly conduct scientific review of medical product dossiers to assess safety, efficacy and quality, inspec...
Article
Full-text available
Access to essential medicines is a key pillar of any health system seeking to deliver universal health coverage. Science-based, independent regulation of medical products is a critical part of ensuring that only quality essential medicines reach the patients who need them. • In this article, we explore the progress the East African Community's Medi...
Article
Full-text available
Independent, science-based regulation of medical products is a critical part of ensuring quality healthcare. When conducted in a transparent, science-based, efficient, accountable, and predictable manner, it can help ensure access to quality products that patients need. • Several factors determine access to medicines, including treatment policy, pr...
Article
Full-text available
• The East African Community (EAC)’s Medicines Regulatory Harmonization (MRH) initiative was created to improve access to quality, safe medicines in the region by simplifying the regulatory process while maintaining a high level of rigor. Building on lessons learned since its launch in 2012, the EAC MRH initiative has created a Roadmap for the Futu...

Citations

... Given the capacity differences in regulating medical products in African Member States, it is important to note that the African Union (AU) Member States and Regional Economic Communities (RECs) are making significant efforts to improve access to safe, quality, and efficacious medical products through strengthening and harmonising medicines regulatory systems. Studies show that the reluctance from companies manufacturing medical products to register their products in African markets is one of the major factors delaying access to medicines (Sillo et al., 2020). Reasons for this reluctance is due to the lengthy application process, the time, expense, and effort needed for this registration process in each NRA (Sillo et al., 2020). ...
... In the long term, the establishment of a regional medicines authority was proposed as a strategy for moving forward. This is not unique to SADC and has also been proposed for other harmonisation initiatives (21,23,24). To do this, a binding memorandum of understanding should be developed mandating the establishment of the regional medicines authority. ...
... With the launch of the EAC-MRH programme, the EAC authorities have made substantial progress in reducing timelines for registration of medical products using the joint review process. A study of the EAC-MRH pilot phase (2012-2017) by Mashingia and colleagues found that registration timelines were reduced from 24 months to 8-12 months for products reviewed using this process (Mashingia et al., 2020). ...