Medicines for Children Initiative

Medicines for Children Initiative ; (IKAM)
legal form	registered association
founding	2013
Seat	Bonn , Germany
main emphasis	Improvement of the situation of pediatric medicines in Germany
Chair	Markus Rudolph
Members	7th
Website	www.arzneimittel4kids.de

Sponsor of the Initiative Arzneimittel für Kinder e. V. (IKAM) are members from the pharmaceutical industry, pharmacists, research and the Federal Association of Pharmaceutical Manufacturers BAH. The association's work is supported by an independent scientific advisory board made up of proven experts. The initiative is based in Bonn - Bad Godesberg ( Plittersdorf district ).

aims

The Medicines for Children initiative has set itself the following goals:

Raising awareness of the topic of pediatric medicines
Improving the health policy framework for the development of medicines for children
Networking of partners who are involved in the field of pediatric medicines
Issuing recommendations for healthcare professionals and patients
Establishing contacts with researchers
Development of strategies and derivation of projects to improve drug safety in children:
- Investigation of the effectiveness and safety of drugs with patented / no longer patented active ingredients
- Development of dosage forms suitable for children
- Collection and systematic evaluation of existing empirical data on the use of drugs in children outside of the approved characteristics (off-label use)
Be a contact for members, industry and politics

The goals set by the initiative result from a number of problems in the use of medicines for children, which have long been known. Solutions to these problems are difficult to find by individual interest groups or participants, but require a joint approach. That is why one of the goals of the initiative is to promote the cooperation of as many interest groups as possible and to create the basis for working together on the problems identified by networking individual organizations.

The association maintains a website where relevant questions about the field are answered and which is aimed at doctors, pharmacists and parents.

Politics is also dealing with these problems. Pediatric medicines were last discussed in the Bundestag's health committee on March 12, 2014. In particular, the report by the EU Commission on the subject of children's medicines in Europe to the European Parliament and the Council, which was presented in June 2013, was discussed. The report is based on a number of new requirements from Regulation (EC) No. 1901/2006 on medicinal products for children .

The Commission's report concludes that many things could have gone better. There is no question, however, that pediatric research has become more and more an integral part of drug research. However, it would be premature to expect final results at this point. The positive effects of the 2007 regulation will only become apparent over the next few years. In addition, this interim analysis revealed the first weaknesses and unnecessary obstacles of the regulation. These are to be closely monitored and discussed in the near future with the EMA regarding the implementation of the regulation.

International

IKAM tries to establish contacts with the pediatric initiatives and networks at European level.

Since 2007 there has been a European regulation Regulation (EC) No. 1901/2006 on medicinal products for children , which aims to improve the availability of medicinal products for children throughout Europe. As described above, the intentions of this regulation are not fully assessed as successful. As the report of the EU Commission shows, this is also due to the lack of support for individual projects by the member states.

The American Food and Drug Administration - FDA - has long had its own program that encourages and demands the special development of drugs for children.

The World Health Organization - WHO - also engages in their work programs the issue of availability of adequate pediatric medicines on, here it is also particularly on the development of child-friendly formulations, Make Medicines Child Size , a