Abstract
Before any medicinal product is authorised for use in adults, it must undergo extensive pharmaceutical consistency and stability tests, toxicological tests and clinical trials to ensure that it is of high quality, safe and effective.The same approach may not always be applied to medicinal products used to treat children.Studies showed that over 50% of the medicinal products used in children may not have been tested for use in this age group. The absence of suitable authorised medicinal products to treat conditions in children results from the fact that pharmaceutical companies do not adapt medicinal products to the needs of the paediatric population. This leaves health care professionals with no alternative other than to use medicinal products "off-label" and to use unauthorised products with the associated risks of inefficacy and/or adverse reactions.The Regulation (EC) No 1901/2006 sets up a system of requirements, rewards and incentives, together with horizontal measures, to ensure that medicinal products are researched, developed and authorised to meet the therapeutic needs of children.The Regulation is addressed to:1. The pharmaceutical industry by setting out the legal framework for receiving rewards and incentives by conducting clinical trials in the paediatric population.2. The Member States to set out to support research into, and the development and availability of, medicinal products for paediatric use.3. The Community as funds for research into medicinal products for the paediatric population shall be provided for in the Community budget in order to support studies relating to medicinal products or active substances not covered by a patent or a supplementary protection certificate.The legal framework for conducting clinical trials, including children/minors, is set up in Directive 2001/20/EC, the Clinical Trials Directive (CTD), for the European Union (EU). The CTD establishes specific provisions regarding conduct of clinical trials, including multi-centre trials, on human subjects involving medicinal products and in particular relating to the implementation of good clinical practice. Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible. The CTD is addressed to all investigators conducting clinical trials including clinical trials in the paediatric population and had to be applied accordingly.In the framework of the authorisation of medicinal products regulated by the Regulation (EC) No 726/2004 and Directive 2001/83/EC as amended and the CTD, and additional implementing Directives and guidelines, the new Regulation (EC) No 1901/2006 is an important new piece of legislation focusing on the requirements to improve the situation for the paediatric population.All Regulations/Directives to be found:
Highlights
In contrast to the situation in adults, more than 50% of the medicines used to treat the children of Europe have not been adequately tested and are not authorised for use in children [1]
Ensure that medicinal products used to treat children are appropriately authorised for use in children, there may be concerns voiced about conducting trials in the paediatric population, this has to be balanced by the ethical issues related to giving medicines to a population in which they have not been tested and their effects, positive or negative, are unknown
4.2 Information Article 28 of the Regulation sets out where authorisation is granted, the results of all those studies shall be included in the Summary of Product Characteristics (SmPC) and, if appropriate, in the Package Leaflet (PL) of the medicinal product, provided that the competent authority deems the information to be of use to patients, whether or not all the paediatric indications concerned were approved by the competent authority
Summary
In contrast to the situation in adults, more than 50% of the medicines used to treat the children of Europe have not been adequately tested and are not authorised for use in children [1]. Ensure that medicinal products used to treat children are appropriately authorised for use in children, there may be concerns voiced about conducting trials in the paediatric population, this has to be balanced by the ethical issues related to giving medicines to a population in which they have not been tested and their effects, positive or negative, are unknown. In order to address the concerns about trials in children it has to be pointed that the requirements for the protection of the paediatric population who take part in clinical trials in the Community laid down in Directive 2001/20/EC of the European Parliament and of the Council of 4th April 2001 In terms of both public health and ethics, it is clearly preferable to test medicines in children, in a safe and controlled clinical trial environment, where the individual child is protected and the studies generate data and information for the benefit of the rest of the children of the EU than to go on with the daily "experiments on children" that today. All information which will be collected in the different routes of getting relevant recommendation to treat children with a medicinal product will be included in the PL and SmPC for each corresponding medicinal product in question
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