Shaping the global innovation and access landscape for better paediatric medicines

Shaping the global innovation and access landscape for better paediatric medicines
Author: World Health Organization
Publisher: World Health Organization
Total Pages: 48
Release: 2022-03-25
Genre: Medical
ISBN: 9240044647

GAP-f’s three-year strategic plan (2022-2024) builds from the work undertaken to date by the network of leading partners, both individually and collectively, through GAP-f. With this strategy, GAP-f is excited to increase its footprint into a broader set of diseases to bring it closer to its vision of all children having equitable access to the medicines they need.

Paediatric drug optimization for neglected tropical diseases

Paediatric drug optimization for neglected tropical diseases
Author: World Health Organization
Publisher: World Health Organization
Total Pages: 56
Release: 2023-11-21
Genre: Business & Economics
ISBN: 9240085173

Priority-setting is the first step to enable a targeted approach to research and development. Developing a prioritized drug portfolio of the most needed formulations for children is essential to streamline researchers’ and supplier’s efforts and resources around specific dosage forms and formulations that address most urgent needs for children. In general, due to limited financial incentives, few new drugs are being developed for Neglected Tropical Diseases (NTDs). Several NTDs disproportionately affect children compared to adults and, as is the case like for most diseases affecting adults and children, the burden to children is compounded by lack of inclusion of paediatric populations in clinical trials and/or lack of age-appropriate dosing regimens and formulations. The PADO-NTD exercise concluded with a final meeting organized in September 2023 with representatives from the four prioritized disease areas to reach consensus on a final PADO-NTD priority list, watch list and research questions and discuss transversal issues for the way forward. The meeting report will include summaries of the background, discussions and deliberations of all PADO exercises, and final conclusions and outputs of the overall PADO for NTD exercises.

Report of the Paediatric Regulatory Network meeting, 12-13 May 2022

Report of the Paediatric Regulatory Network meeting, 12-13 May 2022
Author: World Health Organization
Publisher: World Health Organization
Total Pages: 31
Release: 2024-04-19
Genre: Business & Economics
ISBN: 9240091270

The Paediatric Regulatory Network was initially created as a global paediatric working group in February 2010 in response to a recommendation from the 2008 International Conference on Drug Regulatory Authorities and as part of the World Health Organization (WHO) Better Medicines for Children Project in collaboration with the Bill & Melinda Gates Foundation, to offer a platform for discussion on paediatric regulatory considerations for national regulatory authorities. The Network was reactivated in December 2019 as a global paediatric network supporting the availability of quality-assured medical products for children, by facilitating communication, collaboration, training and regulatory harmonization across the development, registration and pharmacovigilance of paediatric medical products. The Network’s activities contribute efficiently to the implementation of World Health Assembly resolutions WHA60.20 (2007) on better medicines for children, WHA69.20 (2016) on promoting innovation and access to quality, safe, efficacious and affordable medicines for children, WHA67.20 (2014) on regulatory system strengthening for medical products and WHA67.22 (2014) on access to essential medicines.

The selection and use of essential medicines

The selection and use of essential medicines
Author: World Health Organization
Publisher: World Health Organization
Total Pages: 940
Release: 2024-04-19
Genre: Medical
ISBN: 9240089268

The 24th meeting of the WHO Expert Committee on Selection and Use of Essential Medicines was held in Geneva, Switzerland, from 24 to 28 April 2023. The Committee considered 85 applications proposing additions, changes and deletions of medicines, medicine classes and formulations on the Model Lists of Essential Medicines. The Committee evaluated the scientific evidence for effectiveness, safety and cost- effectiveness of the medicines in question. The Committee also considered a review of the age-appropriateness of formulations of essential medicines for children, the AWaRe classification of antibiotics, and other matters relevant to the selection and use of essential medicines.

Pediatric Drug Development

Pediatric Drug Development
Author: Andrew E. Mulberg
Publisher: John Wiley & Sons
Total Pages: 782
Release: 2013-05-20
Genre: Medical
ISBN: 1118312058

Most medicines have never been adequately tested for safety and efficacy in pediatric populations and preterm, infants and children are particularly vulnerable to adverse drug reactions. Pediatric Drug Development: Concepts and Applications, Second Edition, addresses the unique challenges in conducting effective drug research and development in pediatric populations. This new edition covers the legal and ethical issues of consent and assent, the additional legal and safety protections for children, and the appropriate methods of surveillance and assessment for children of varying ages and maturity, particularly for patient reported outcomes. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of global pediatric drug development. It also encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children globally. From an international team of expert contributors Pediatric Drug Development: Concepts and Applications is the practical guide to all aspects of the research and development of safe and effective medicines for children.

Paediatric drug optimization standard procedure

Paediatric drug optimization standard procedure
Author:
Publisher: World Health Organization
Total Pages: 24
Release: 2021-11-19
Genre: Medical
ISBN: 924003952X

The aim of this document is to provide guidance on how to undertake a paediatric drug optimization (PADO) exercise and identify key priority products for research and development. This guidance is for all technical units undertaking a PADO exercise, all stakeholders involved in PADO processes as well as interested organizations and experts involved in the research and development of therapeutics in the public and private sectors.