As the World Health Organization (WHO) reports that one third of the world’s population does not have timely access to the healthcare products they require, the efficient, predictable and speedy assessment and introduction of quality new medicines and vaccines to underserved patient populations continues to be a priority for the whole healthcare community. (1)
A country’s national regulatory authority is mandated to ensure the quality, safety and efficacy of medicinal products which launch into their markets. Regulators in low and middle-income countries (LMICs) strive to develop fit-for-purpose regulatory systems as inefficiencies can translate into long and unpredictable review times for medicines – resulting in delays to their registration. These inefficiencies can also affect the authorisation of competitive generic and biosimilar products, which has an impact on the costs and availability of many medicines.
Timely access to new medicines and vaccines may be addressed through the strengthening of registration efficiencies and timelines, by establishing and refining value-added registration processes, resources and systems.
To this end, we are proud to share that the Centre for Regulatory Science (CIRS) has been awarded a phase two grant of $1.09m by the Bill & Melinda Gates Foundation to continue our collaborative endeavours to expedite patient access to medicines in specific areas of greatest medical need by tracking regulatory performance metrics in low and middle income countries. This unique metrics collection programme will continue to inform, monitor and assess the effectiveness of regulatory optimisation programmes to equip agencies in Africa, Latin America, the Middle East and Asia to achieve targeted improvements in regulatory performance goals and ultimately, to accelerate registration of quality medicines and vaccines in these countries.
The grant will also allow CIRS to provide opportunities for emerging national regulatory agencies to come together at regional forums in Africa, Latin America and Asia, as the sharing of experiences is a key way that regulators identify important new ways to improve their organisational efficiency and learn about tools and processes that will help build best regulatory assessment practices.
The Centre for Innovation in Regulatory Science (CIRS) has provided unique insights into the performance of companies, regulatory agencies and health technology assessment (HTA) bodies through its metrics programmes for more than 20 years. Through the OpERA programme (Optimising Efficiencies in Regulatory Agencies) it combines qualitative and quantitative information to provide a detailed picture of the regulatory assessment activities of agencies at any stage of maturity and provides each country with a country report which permits global comparisons to similar agencies and encourages the sharing and adoption of good review practices.
For example, last year we published a study with the South African regulatory agency SAHPRA, which identified and measured key milestones and timelines in its review process from 2015-2018. This led to several recommendations for improvement, including monitoring of milestones and implementing facilitated regulatory pathways, which will hopefully help SAHPRA to reduce its significant approval times and deliver much needed medicines to patients in South Africa. South Africa is just one of several LMICs that the renewed foundation grant will target.
Dr Jamie Munro is Executive Director at the Centre for Innovation in Regulatory Science – a neutral, independent U.K.-based subsidiary of Clarivate. The centre provides an international forum for industry, regulators, HTA bodies and other healthcare stakeholders to meet, debate and develop regulatory and reimbursement policy through the innovative application of regulatory science. For more information: www.CIRSci.org
(1) Keyter, A., Salek, S., Gouws, J. et al. Evaluation of the Performance of the South Africa Regulatory Agency: Recommendations for Improved Patients’ Access to Medicines. Ther Innov Regul Sci (2019). https://link.springer.com/article/10.1007/s43441-019-00013-5