Parameters will inform, monitor and evaluate the effectiveness of regulatory optimization programs
LONDON, March 9, 2020 / PRNewswire / – The Center for Innovation in Regulatory Science (CIRS), a neutral and independent international organization whose members are based in the United Kingdom, has received a Phase II grant from $ 1.09 million by the Bill & Melinda Gates Foundation to continue their collaborative efforts to accelerate patient access to medicines in specific areas with the greatest medical needs in low and middle income countries (PRITI) *1.
The grant was awarded to CIRS with the aim of “ monitoring regulatory performance measures in low and middle-income countries ” to accelerate and consolidate activities around a single program of collection of measures which aims to help PRFM to achieve targeted improvements to regulatory performance targets and ultimately accelerate the registration of quality drugs in these countries.
PRFI regulators strive to develop regulatory systems tailored to their needs, particularly those related to the review, evaluation and approval of drugs, including vaccines. Inefficiencies, particularly redundancies, in the process can result in long and unpredictable review times for drugs, resulting in delays in their registration. These inefficiencies can also affect the authorization of competitive generics and biosimilars, which has an impact on the costs and availability of many drugs.
CIRS has been collecting data assessing regulatory marketing authorizations for more than 20 years, particularly in high-income countries, and has developed a standardized reporting approach to identify key characteristics likely to have an impact. on regulatory performance in order to allow a precise interpretation of the parameters evaluated. With this data, regulatory authorities have been able to continually improve their performance relative to their own goals and compared to the performance of peer agencies.
Thanks to the OPS program of CIRS (Optimizing Efficiency in Regulatory Agencies), it combines qualitative and quantitative information to provide a detailed picture of the regulatory assessment activities of agencies at all stages of maturity and provides each country with a national report which allows global comparisons with similar agencies. and encourages the sharing and adoption of good review practices.
The grant will also enable CIRS to provide opportunities for emerging national regulatory bodies to come together in regional forums. Africa, Latin America, and Asia during the three years of the grant. Sharing experiences is an essential way for regulators to identify important new ways to improve their organizational efficiency and learn about the tools and processes that will help establish best regulatory assessment practices.
Jamie Munro, Executive director, CIRS said: “Efficient, predictable and rapid evaluation and introduction of new quality drugs and vaccines for underserved patient populations continues to be a priority for the entire health care community. The objectives of phase two of this program are to give PRITI regulatory bodies the tools and information to measure themselves against the results of their evolving product evaluation processes; while making the transition from the OpERA program to a financially autonomous metric performance monitoring system for the continuous use of participating agencies. ”
*1 The following target countries and regional regulatory initiatives are central to this grant renewal:
Africa: Ethiopia, East African Community (EAC), Zazibona initiative (in particular, the original members: Zambia, Zimbabwe, Botswana & Namibia), West African Health Organization (WAHO – in particular Ghana, Nigeria, Burkina Faso & Senegal) and the South African Health Products Regulatory Authority (SAHPRA).
Latin America: Brazil, Mexico, Peru, Haiti, CARICOM (Caribbean Community).
Asia/Middle East: India, Indonesia, Vietnam, Malaysia, Philippines, Singapore, Thailand, China, Gulf Health Council (GHC).
Sure the Center for Innovation in Regulatory Science (CIRS): The mission of CIRS is to maintain a leadership role in the identification and application of scientific principles with the aim of advancing policies and regulatory and assessment processes for health technologies. CIRS provides an international forum for industry, regulators, HTA organizations and other health stakeholders to meet, debate and develop regulatory and reimbursement policy through the innovative application of regulatory science. It is governed and operated for the sole support of the activities of its members. The organization has its own management and advisory boards, and its funding comes from membership fees, related activities and grants. It is a neutral and independent UK-based subsidiary of Clarivate Analytics plc (NYSE: CCC; CCC: WS). For more information: www.cirsci.org
Forward-looking statements: This press release and the oral statements contained in this document may contain forward-looking statements regarding CIRS. Forward-looking statements provide current CIRS expectations or forecasts regarding future events and may include statements regarding expected results, synergies and other future expectations. These statements involve risks and uncertainties, including factors beyond the control of CIRS, which may cause material differences between the actual results. CIRS assumes no obligation to update or revise the statements made here, whether as a result of new information, future events or otherwise.
Contact with the media:
Lisa Hulme – Global scientific communications manager
e: [email protected] m: +44 (0) 7464 646536
SOURCE The Center for Innovation in Regulatory Science
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