The US Food and Drug Administration (FDA) on Tuesday announced it’s forging a cooperative agreement with the World Health Organization (WHO) to support further regulatory systems strengthening, development of new norms and standards and research to advance global access to safe and effective biologics that meet international standards.
FDA's Center for Biologics Evaluation and Research (CBER) anticipates providing up to $2 million in FY 2016 to support the project, as well as a possible additional $2 million for each year through FY 2020.
Since 1998, CBER has been a Pan American Health Organization/WHO Collaborating Center for Biological Standardization, and its current commitment runs until 2020 though future extensions are expected.
“As a WHO Collaborating Center for Biological Standardization, CBER has provided scientific and technical support to WHO for development of international standards, strengthening regulatory systems, advancing product safety and vigilance, vaccine prequalification, and research activities to advance development and improve standardization of vaccines and other biologicals,” FDA says.
Providing adequate regulatory oversight throughout the product life cycle (pre- and post-licensure) is a major challenge for national regulators, though it’s essential for assuring the safety, purity and potency of vaccines and other biologics.
However, FDA notes that many regulators are “confronted by a steadily increasing number of novel products, complex quality concerns, new regulatory issues arising from rapid technical and technological advances, and emerging infectious diseases (e.g., pandemic influenza, Middle East Respiratory Syndrome, Ebola, Zika).”
In 2009, FDA entered into a confidentiality arrangement with WHO to enable CBER to serve as a national regulator of record in the vaccine prequalification program, and it currently serves in this capacity for nine US licensed, WHO-prequalified vaccines.
FDA outlines four main goals for the $2 million project:
- Contribute to the knowledge base of the current state of regulatory oversight of vaccines and other biologics;
- Provide technical support to strengthen regulatory systems at the national and regional level;
- Develop global norms and standards; and
- Support regulatory science and other activities to promote the development and increased access to safe and effective biologics.
As part of CBER’s work with WHO, the funds will help support assessments and analyses, particularly on vaccine regulatory capabilities and pharmacovigilance, as well as the development of an institutional plan to enhance regulatory performance in low- and middle-income countries.
CBER is also looking to strengthen regulatory systems at the national and regional levels around good manufacturing, clinical, and laboratory practices; monitoring and evaluation of product quality; lot release; inspection and surveillance of products throughout the supply chain; pharmacovigilance systems building and analyses; risk assessment and analysis and management.
The partnership may also help enable the timely sharing of scientific findings and data through international collaboration to develop WHO International Biological Reference Preparations and WHO guidelines and recommendations on the production and control of vaccines and other biological products and technologies.
WHO must apply for the funds by 5 July.
Collaboration in Regulatory Systems Strengthening and Standardization Activities To Increase Access to Safe and Effective Biological Products