Lag in regulatory approval for new drugs costly: Experts

03 Oct, 2019 - 00:10 0 Views

The Herald

Paidamoyo Chipunza in Victoria Falls
African regulatory authorities of medical products are intensifying efforts towards improving accessibility to newer and effective medicines on the market amid revelations that many patients were dying from treatable conditions as they fail to access medicines due to lengthy registration processes.

Presenting findings of a study titled “Making a Case: How Regulatory Harmonisation can save Lives in Africa at the 4th biennial Scientific Conference on Medical Products Regulation in Africa (SCoMRA IV) held in Victoria Falls, a global health innovation organisation-PATH advocacy manager Mr Sibusiso Hlatjwako said more than 23 000 lives can be saved should the process of approving new entrants is reduced by at least two years.

He said should the process be reduced to one year, it could save an estimated 11 000 lives. Mr Hlatjwako said the lag in regulatory approval of new health products in sub-Saharan Africa is typically four to seven years after first regulatory submission in high-income countries, a process he said contributed to delayed availability of newer and effective medicines to patients.

“Scientific advances have led to the creation of new vaccines, medicines, diagnostics, and devices that have saved millions of lives. Yet new products may not be readily accessible to those in need due to a variety of factors, including systemic challenges caused by weak regulatory oversight, particularly in low-and middle-income countries,” he said.

He said regulatory harmonisation was the way to go to reduce this prolonged period to give patients access to newer and effective medicines. Regulatory harmonisation, which the African Union member states are pushing for through the African Medicines Regulatory Harmonisation (AMRH) since 2009, involves sharing of information such as inspection findings between regulatory authorities, aligning safety and efficacy standards and processes used to assess and monitor research and products.

The process also involves conducting joint reviews of research protocols and product dossiers and inspections of research and manufacturing sites and mutual recognition of assessments and inspections conducted and decisions made by other regulatory authorities, processes that are expected to reduce registration periods of medical products entrants.

Speaking at the same occasion, Ms Wainona Rei Bollislis from the Sanofi Pasteur- a global vaccine organisation urged African countries to make use of technology to intensify and enhance the harmonisation process. Ms Bollislis said new technology such as cloud-based solutions redefined the way pharmaceutical companies share data with regulators for faster and efficient processes.

She said adopting this technology in the context of harmonisation would assist in regulatory alignment, reduce country-specific requirements and sharing of information and good practices on lifecycle management of medical products

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