32006R1901

WHAT IS THE AIM OF THE REGULATION?

The regulation aims to:

• encourage high-quality research into the development of medicines for children;
• guarantee — over time — that the majority of these are specifically authorised for such use;
• ensure the availability of accurate and helpful information on paediatric drugs.

KEY POINTS

Pharmaceutical companies must work with the European Medicines Agency — set up under Regulation (EC) No 726/2004 (see summary) — to draw up and agree on paediatric investigation plans whose aim is to collect clinical data on the use of a medicine in children. The results of the paediatric investigation plan have to be submitted when applying for authorisation to market the medicinal products. In exchange, and as a reward, a company receives a 6-month extension of its supplementary protection certificate — a form of intellectual property right. For orphan medicines, a manufacturer has an extra 2 years of market exclusivity.

An independent paediatric committee inside the European Medicines Agency, advises on questions raised regarding children’s medicines and is responsible for the scientific assessment and approval of the paediatric investigation plans.

The regulation introduces:

• an EU inventory of the therapeutic needs of children that focuses the research, development and authorisation of medicines;
• an EU network of investigators and trial centres that carries out research;
• a system of free scientific advice for the industry;
• a public database of paediatric studies.

Amendments to the regulation

Regulation (EU) 2019/5 amends Regulation (EC) No 1901/2006 in order to take into account that the specification of obligations that are subject to financial penalties are now laid down in Regulation (EC) No 726/2004 together with the powers that allow the Commission to lay down procedures for imposing such financial penalties.

Review and evaluation of the regulation

In 2017, the European Commission published a review of the 10 years of the regulation’s operation. It reports that:

• the regulation had an important impact on the development of paediatric medicines in the EU;
• considerable progress was seen in the availability of medicines for children in certain therapeutic fields, particularly in the fields of rheumatology and infectious diseases;
• from 2007-2016, over 260 new paediatric medicines were authorised and the number of agreed paediatric investigation plans increased significantly;
• in the area of research, there have been positive results, particularly in areas where the needs of adult and paediatric patients overlap, although in diseases that are rare and/or unique to children, and which, in many cases, are equally supported through Regulation (EC) No 141/2000 on orphan drugs (see summary), major therapeutic advances often failed to materialise.

An evaluation of the paediatric regulation, along with the orphan drugs regulation, took place in 2019 and 2020. The evaluation involved several steps, including the publication of a roadmap, studies on paediatric medicines and on medicines for orphan diseases, and a wide consultation of interested parties. Following the results of this evaluation, an impact assessment for a revision of these two regulations has been launched.

FROM WHEN DOES THE REGULATION APPLY?

The regulation has applied since 26 January 2007 with the exception of 4 of its articles:

• Article 7 (applications for marketing authorisations) has applied since 26 July 2008;
• Article 8 (authorised medicinal products protected either by a supplementary protection certificate or by a patent which qualifies for the granting of the supplementary protection certificate) has applied since 26 January 2009; and
• Articles 30 and 31 (paediatric use marketing authorisation) have applied since 26 July 2007.

BACKGROUND

For more information, see:

• Medicines for children (European Commission)
• Paediatric regulation (European Medicines Agency).

MAIN DOCUMENT

Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, pp. 1-19)

Successive amendments to Regulation (EC) No 1901/2006 have been incorporated into the original text. This consolidated version is of documentary value only.

RELATED DOCUMENTS

Report from the Commission to the European Parliament and the Council: State of paediatric medicines in the EU — 10 years of the EU paediatric regulation (COM(2017) 626 final, 26.10.2017)

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, pp. 1-33)

See consolidated version.

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, pp. 67-128)

See consolidated version.