Metrics will inform, monitor and assess the effectiveness of regulatory optimisation programmes
The grant has been awarded to CIRS for the purpose of 'Tracking Regulatory Performance Metrics in Low and Middle Income Countries' to accelerate and consolidate the activities around a unique metrics collection programme which aims to assist LMICs achieve targeted improvements in regulatory performance goals and ultimately, to accelerate registration of quality medicines in these countries.
Regulators in LMICs strive to develop fit-for-purpose regulatory systems, in particular, those related to the review, assessment and approval of medicines, including vaccines. Inefficiencies, especially redundancies, in the process 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.
CIRS has collected regulatory marketing authorisation assessment data for more than 20 years, especially in high-income countries, and has developed a standardised reporting approach to identify key characteristics that may impact regulatory performance to allow accurate interpretation of the metrics being evaluated. With such data, regulatory authorities have been able to continually improve their performance against their own goals and against the performance of peer agencies.
Through CIRS' 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.
The grant will also allow CIRS to provide opportunities for emerging national regulatory agencies to come together at regional forums in
*1 The following target countries and regional regulatory initiatives are the focus of this grant renewal:
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Forward-Looking Statements: This press release and oral statements included herein may contain forward-looking statements regarding CIRS. Forward-looking statements provide CIRS' current expectations or forecasts of future events and may include statements regarding results, anticipated synergies and other future expectations. These statements involve risks and uncertainties including factors outside of CIRS' control that may cause actual results to differ materially. CIRS undertakes no obligation to update or revise the statements made herein, whether as a result of new information, future events or otherwise.
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