Regulation (EC) No. 1901/2006 on medicinal products for children

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Regulation (EC) No. 1901/2006

Title: Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of December 12, 2006 on medicinal products for children and amending Regulation (EEC) No. 1768/92, Directives 2001/20 / EC and 2001/83 / EC as well as of Regulation (EC) No. 726/2004
Designation:
(not official) 		Pediatric Medicines Ordinance
Scope: EEA
Legal matter: Pharmaceutical law
Basis: EGV , especially Art. 95
Procedure overview: European Commission
European Parliament
IPEX Wiki
To be used from: January 26, 2007
Reference: OJ L 378 of 27.12.2006, pp. 1-19
Full text Consolidated version (not official)
basic version
Regulation has entered into force and is applicable.
Please note the information on the current version of legal acts of the European Union !

The Regulation (EC) no. 1901/2006 on children's medicines is a European Union regulation that governs the development of drugs use in children and adolescents (0 to 17 years), including. It came into force in January 2007 and is intended to ensure that drugs are also available for the treatment of children and adolescents whose efficacy and safety have been investigated appropriately and ethically justifiable especially for this target group.

background

The legal framework for clinical studies in children is more restrictive than for adults due to ethical concerns. However, in a number of cases, particularly in the case of very serious or rare diseases, the clinical situation requires treatment with drugs that are not approved for this age group. In Germany in 2008 over half of the drugs used in children and adolescents had not been tested on children and were not approved for children. They are used in so-called off-label use , whereby the results of clinical trials on adults are simply transferred to children. In 2004, the 12th amendment to the German Medicines Act improved the requirements for clinical studies with minors for the first time. Although only sick children are still allowed to participate in clinical studies (exception: studies on prevention or diagnostics), what is new is that the expected benefit does not have to be justified solely with regard to the sick child, but also with a benefit for other children who are suffering from the same disease, may be justified.

The Pediatric Medicines Regulation was enacted to continue promoting the development of medicines for children across the EU. At the same time, the aim is to avoid exposing children and adolescents to unnecessary studies and delaying approval for use in adults.

Obligation to conduct children's studies

Since July 2008, Europe for each newly registered drugs with the application for admission a pediatric investigation plan ( Pediatric Investigation plan , PIP ) submitted where the proposed development program is described for use in children or adolescents. This does not apply to certain medicinal products such as generics , biosimilars , medicinal products with at least 10 years of general medical use in the EU, as well as homeopathic and traditional herbal medicinal products . The investigation plan submitted by the applicant is from a specially set up at the European Medicines Agency scientific committee, the Pediatric Committee judged (PDCO). In certain cases, the pharmaceutical companies can request a deferral or an exemption from the obligation to submit a pediatric investigation plan (deferral, waiver). The approval of the test concept or the release or deferment is a prerequisite for processing the approval application by the authority. The application for extensions also requires the submission of a pediatric investigation plan.

Approved for pediatric use

For drugs that have already been approved for adults, pharmaceutical companies can also apply for approval for pediatric use ( Pediatric use marketing authorization , PUMA ). Such approval can be granted for pediatric indications (in selected age groups or for the entire age group up to 17 years) or for dosage forms suitable for children. A PUMA also requires studies according to a pediatric investigation plan that must be approved in advance by the Pediatric Committee.

Discounts for pharmaceutical companies

To compensate for the additional requirements, pharmaceutical companies are granted discounts. A distinction must be made between whether medicinal products contain active substances protected by patent law or not. There are special regulations for drugs against rare diseases ( orphan drugs ). Medicines that have been approved in accordance with the requirements of the Pediatric Medicines Ordinance are marked with a special symbol for suitability for children.

Medicines with active ingredients protected by patent

In the case of pharmaceuticals whose active ingredients are still subject to commercial protection periods , the holder of the patent or a supplementary protection certificate is granted a six-month extension of the protection period, regardless of whether the children's studies lead to approval for children or not.

Medicines with active ingredients that are not protected by patent

Pharmaceutical companies receive ten years of marketing protection for drugs with active ingredients not protected by patent for an additionally approved pediatric use (PUMA) (eight-year document protection for the data collected on children plus two-year market exclusivity).

Central registration

In order to avoid unnecessary repetition of studies with children worldwide, the regulation stipulates that the register of clinical studies of the EU should also contain a register of clinical trials of medicinal products for children. This is intended to record all ongoing, completed and prematurely terminated pediatric studies in the Community and in third countries. The information in the database must be made available to the public in certain extracts.

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