Call for public consultation: Target product profile for paediatric formulation of Nitrofurantoin and Azithromycin

Deadline for the call is 2 December 2024

15 October 2024
Call for consultation

Bacterial infections remain the leading cause of infectious mortality among children under five years of age worldwide. Despite the availability of various antibiotic classes, significant challenges persist in treating pediatric bacterial infections, including limited access to existing medicines and a lack of investment in antibiotic research, particularly for children. Indeed, across many disease areas, the development of pediatric medicines lags behind adult treatments by nearly a decade, largely due to insufficient investment and weak market incentives.

Following the resolution at the Sixty-ninth World Health Assembly on promoting innovation and access to quality, safe, efficacious, and affordable medicines for children, WHO and partners in the Global Accelerator for Paediatric Formulations Network (GAP-f) have increased their efforts to deliver on this global commitment and have scaled up activities to ensure that age-appropriate formulations are available for children.

On 24 March 2023, WHO launched its first-ever list of priority pediatric antibiotic formulations, aiming to focus research and development on the specific needs of infants and children. Following this, a TPP development group, consisting of scientific, clinical, and public health experts from diverse geographic regions was established to develop a target product profile (TPP) for selected priority formulations and provide clear guidance for manufacturers and product development partnerships.

The World Health Organization is now seeking feedback on azithromycin and nitrofurantoin draft TPPs from industry experts, product developers, the scientific community, implementers, clinicians, and health programme personnel currently involved in the management of infectious diseases. 

TPP on Nitrofurantoin

TPP on Azithromycin

Deadline for the call is 2 December 2024

Media Contacts

Laura Keenan

Communications officer
World Health Organization

Telephone: +41 79 500 65 64

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