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International Federation of Pharmaceutical Manufacturers & Associations




  • The international community recognized the need to facilitate the development and availability of medicines for children, and to improve the availability of information on their use, without subjecting children to unnecessary trials, or delaying the authorization of medicines for use in adults.
  • The IFPMA collaborates with the World Health Organization, regulatory bodies and other key stakeholders to share industry’s extensive experience in pediatric medicine development and contribute to the development of effective public policies to increase the availability of safe and effective pediatric medicines and child-appropriate formulations.
  • Specific pediatric formulations are desirable to provide appropriate dosing and administration.
  • Incentives for encouraging R&D and market uptake of pediatric medicines are important policy measures.
  • Public-Private Partnerships can play an important role in the development of safe and effective pediatric formulations especially for treating diseases prevalent in developing countries.

Background

According to the WHO, improving children’s health requires investment in all of the health system’s building blocks from trained workforces, information on which to base treatment decision and logistics to deliver medicines and technologies, to increased research into child-size formulations with proven efficacy and safety.

Pharmacists, parents and caregivers often resort to manipulation of adult medicines to treat children (e.g. breaking tablets without score line). This can be hazardous for children as they may affect stability, uptake of medicines in the child body and accuracy of dosing of a medicine. Specific formulations developed for children are therefore often needed, but besides medical need, considerations on the technical, ethical and financial challenges to global research and development of pediatric medicines should be taken into account.

Pediatric Formulations:

Development of age-appropriate formulations should be balanced with scientific risk/benefit considerations, which should lead to an optimized pediatric medicine. This may vary on a case-by-case basis depending on factors such as the disease to be treated (acute vs. chronic), the physiochemical properties of the active substance, the ability of the end-user and caregiver to administer the product, the age of the child and on any other related scientific evidence. Besides technical considerations, a specific pediatric formulation should provide flexibility in dosing and administration to children of different ages and must also be possibly developed within an acceptable time period allowing subsequent access to patients.

Global Pediatric Research:

Globalization of pediatric research is nowadays necessary to make the best use of scientific resources in all regions and to ensure that scientifically robust data are generated to inform all healthcare providers on the appropriate use of those medicines. In this regard, convergence and acceptability of regulatory requirements (e.g. ICH E11 and E3) as well as acceptability of clinical data from other countries are prerequisites to avoid unnecessary repetition of clinical trials in children.

Ethical Considerations:

From an ethical standpoint, a robust legal and regulatory structure with adequate protections for all populations of patients, including children, is of paramount importance. R&D pharmaceutical companies apply fundamental ethical and scientific standards to any clinical research done anywhere in the world.

Finally, if an innovative medicine doesn’t reach children, it can’t cure them. Adequate incentives to stimulate more R&D for pediatric medicines as well as strong international and non-governmental advocacy are needed to drive successful development, introduction, adequate access, supply and uptake of pediatric formulations. 

Taking all into consideration, the pharmaceutical industry is committed to and strongly encourages early collaboration among all stakeholders to develop safe and effective pediatric medicines and to ensure timely access to innovative treatment.

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