Medicinal Products For Paediatric Use Research Articles

Pharmaceutical policies in post-communist Albania: Progress and challenges toward European Union membership

Aim: Shifting from a communist regime to a democratic system has affected health system fundamentally in most of the Western Balkan countries including Albania. Albania became a European Union (EU) candidate country in 2014. Since then, one of the main concerns has been to approximate the legislation with the EU framework. The aim of this paper is to review the evolvement of pharmaceutical legislation in Albania and challenges toward achieving full approximation to the EU’s respective legislation.
 
 Methods: We used qualitative techniques, especially means of conventional content analysis and two sources to collection data. First, we consulted the Albania’s National Publications Office webpage and analysed all available legislation regarding “pharmacy”, “medicine” and “pharmaceutical products” from 1994 to 2021. Then, we analysed the National Integration Plans that have been published by the Government of Albania from 2014 to 2021.
 
 Results: The decrease of the price margin system goes in parallel with the increase of the pharmaceutical expenditure, including out-of-pocket expenditure on medicines and lack of adequate and sensitive reimbursement policies. The main pillars of the pharmaceutical sector in Albania are well-covered legally but not fully in concordance with the EU framework.
 Conclusion: There is a need to foster laws implementation that regulate the opening of pharmacies; a detailed regulation on pharmacovigilance; and a regulation on medicinal products for paediatric use. Also, the existing legal framework should be aligned with the European one. Medicine pricing methods should go in the same line with the decrease of out-of-pocket expenditure.

Registration of medicinal products for pediatric use and Pediatric Investigation Plan

Registration of medicinal products for pediatric use and Pediatric Investigation Plan

Pharmaceutical policies in post-communist Albania: Progress and challenges toward European Union membership

Aim: Shifting from a communist regime to a democratic system has affected health system fundamentally in most of the Western Balkan countries including Albania. Albania became a European Union (EU) candidate country in 2014. Since then, one of the main concerns has been to approximate the legislation with the EU framework. The aim of this paper is to review the evolvement of pharmaceutical legislation in Albania and challenges toward achieving full approximation to the EU’s respective legislation. Methods: We used qualitative techniques, especially means of conventional content analysis and two sources to collection data. First, we consulted the Albania’s National Publications Office webpage and analysed all available legislation regarding “pharmacy”, “medicine” and “pharmaceutical products” from 1994 to 2021. Then, we analysed the National Integration Plans that have been published by the Government of Albania from 2014 to 2021. Results: The decrease of the price margin system goes in parallel with the increase of the pharmaceutical expenditure, including out-of-pocket expenditure on medicines and lack of adequate and sensitive reimbursement policies. The main pillars of the pharmaceutical sector in Albania are well-covered legally but not fully in concordance with the EU framework. Conclusion: There is a need to foster laws implementation that regulate the opening of pharmacies; a detailed regulation on pharmacovigilance; and a regulation on medicinal products for paediatric use. Also, the existing legal framework should be aligned with the European one. Medicine pricing methods should go in the same line with the decrease of out-of-pocket expenditure.

PO-0930 Enpr-ema, A Platform For Disseminating Good Practices About Paediatric Medicines Research Across Europe And With International Partners

Background and aims The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) was set up in accordance with Article 44 of the Paediatric Regulation 1 . Enpr-EMA is a network of research networks, investigators and centres with recognised expertise in performing clinical studies in the paediatric population with the mission of facilitating studies in order to increase the availability of medicinal products authorised for use in the paediatric population 2 . Methods To register with Enpr-EMA, networks must fulfil the requirements laid down by a set of six recognition criteria for quality of paediatric research (Figure 1). Enpr-EMA Working Groups have recently been established (Table 1) to address important issues. Results There are currently 38 registered networks or centres 3 (Table 2). Past work includes supporting the development of 3 new networks; disseminating good practice relating to the involvement of children and young people in research. Ongoing work includes: sharing good practice within Enpr-EMA and Industry Partners; developing a check list of Ethics Committee submission documents; a roadmap to lobby the European Commission about the need to support medicines development in children; establishing a joint PDCO/Enpr-EMA Working Group on neonatology; initiating collaboration with paediatric networks in the USA. Conclusions After successful implementation of Enpr-EMA as a platform for sharing good practices among paediatric clinical trials networks 4 , Enpr-EMA is addressing some important hurdles to the development of medicines for children. Enpr-EMA invites paediatric centres/investigators to contribute to its work and/or become a member. Acknowledgments Not applicable. References 1 Regulation (EC) No 1901/2006 of the European Parliament and 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 2 Ruperto et al . A European network of paediatric research at the European Medicines Agency (Enpr-EMA). Arch Dis Child 2012;97(3):185–8 3 Enpr-EMA webpages: http://www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/general/general_content_000303.jsp and mid=WC0b01ac05801df74a 4 5-year report to the European Commission. General report on experience acquired as a result of the application of the Paedi-atric Regulation, prepared by the European Medicines Agency with its Paediatric Committee: http://ec.europa.eu/health/files/paediatrics/2013_com443/paediatric_report-com (2013)443_en.pdf

Blood endocrine disruptor levels in cryptorchidic newborns

Non-clinical safety evaluation using juvenile animals is becoming more important in development of medicinal products for paediatric use. It is considered that many physiological changes occur in juvenile animals during their development and this could affect toxicokinetics (TK) and toxicodynamics (TD) of some drugs. However, the changes in TK caused by physiological development have not been fully investigated. Our previous study showed many differences between juvenile and adult rats, in concentration of serum proteins, mRNA expression of CYP enzymes and transporters, and so on. In this study, TK analysis of single dose study in juvenile rats treated with quinidine, which binds mainly to a1-acid glycoprotein (AGP), was conducted to assess the impact on TK. Quinidine at a dose of 30mg/kg was administered intravenously to 14-, 21and 49-day-old rats (n=4/sex/age), and its concentration in plasma was analyzed. As a result, the AUCall of quinidine decreased with sex maturation between 21and 49-day-old rats from 10,500 to 6900ngh/mL (males), and from 8200 to 5710ngh/mL (females). This decrease is considered to be caused mainly by faster elimination of quinidine in 49-day-old rats because z, the elimination rate constant, increased with age between 21and 49-day-old rats from 0.290 to 0.660 (1/h) in males, 0.306 to 0.842 (1/h) in females. In this presentation, the mechanism of these differences and its impact on TK will be discussed.

Pediamécum: un año de experiencia

In 2011, the Spanish Association of Pediatrics decided to support the most ambitious project of its newly created Committee for Medicinal Products: Pediamécum. This is the first free on-line database with information on medicinal products for pediatric use in Spain. The web page http://pediamecum.es/ started on December 17 December 2012. One year later, Pediamécum includes 580 registered drugs. The website achieved more than one million page views by the end of 2013. Because of the first anniversary of Pediamécum, a survey was performed to request the feeling of users. Four hundred eighty-three responses were obtained. Ninety-five percent believed that it is easy to navigate through the web, and 74% said that their doubts about the use of medicines in children were always resolved. The overall rating of Pediamécum is 7.5/10. The aims of Pediamécum are being accomplished; which is reflected essentially due to it becoming a useful tool for all professionals who care for children in their daily clinical practice.

Navigating the Maze of IP/regulatory Rights in the EU: the Complex Interaction Between the SPC and Pediatric Regulations

Pharmaceutical Patent AnalystVol. 2, No. 2 Hot TopicNavigating the maze of IP/regulatory rights in the EU: the complex interaction between the SPC and Pediatric RegulationsMaria Isabel Manley & Marina VickersMaria Isabel Manley* Author for correspondenceBristows LLP, 100 Victoria Embankment, London EC4Y 0DH, UK. Search for more papers by this authorEmail the corresponding author at marie.manley@bristows.com & Marina VickersBristows LLP, 100 Victoria Embankment, London EC4Y 0DH, UKSearch for more papers by this authorPublished Online:26 Feb 2013https://doi.org/10.4155/ppa.13.7AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail View articleReferences1 Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products.Google Scholar2 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.Google Scholar3 Dr Reddy’s Laboratories (UK) Ltd and Dr Reddy’s Laboratories Ltd v. Warner-Lambert Company LLC, EWHC 3715 (Pat) (2012).Google Scholar4 Council Regulation (EEC) No 1768/92 concerning the creation of a supplementary protection certificate for medicinal Products (now repealed and replaced by Regulation (EC) No 469/2009).Google Scholar5 Merck Sharp and Dohme Corp (previously Merck and Co) v. Deutsches Patent- und Markenamt, Case C-125/10 (2011).Google Scholar6 EI Du Pont de Nemours & Co v. UK Intellectual Property Office, EWCA Civ 966 (2009).Google ScholarFiguresReferencesRelatedDetails Vol. 2, No. 2 Follow us on social media for the latest updates Metrics Downloaded 90 times History Published online 26 February 2013 Published in print March 2013 Information© Future Science LtdFinancial & competing interests disclosureThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.PDF download

Challenges in incentivizing the pharmaceutical industry to supporting pediatric oncology clinical trials

In high-income countries cancer is the leading cause of disease-related death in children older than 1 year of age and therefore represents a significant public health burden. However, pediatric cancer represents only approximately 1% of all cancer cases in the Western world and all childhood cancers are individually rare (incidence <6/100,000 per year) [101]. Pediatric oncology is therefore of negligible significance to pharmaceutical companies, compared with the adult market. Historically, several additional noncommercial barriers have also been highlighted as possible blocks to drug development in childhood cancer: rare populations leading to slow accrual and small samples sizes for conventional trial designs, the need for suitable pediatric formulations (tablets and capsules are less appropriate than intravenous or liquid formulations), concerns for both acute and long-term safety in the developing child and anxiety over real and perceived ethical difficulties in studying new agents in this vulnerable population [1]. This has meant that pediatric oncologists have been obliged to prescribe drugs off-label as there is no suitable alternative and the dose and schedule are often empirical, based on extrapolation from adult data and historical experience of relatively safe usage, without appropriate pharmacokinetic information. To try and tackle this gridlock, the regulators on both sides of the Atlantic have tried to incentivize and mandate pediatric investigations in order to license a drug for an adult indication. The USA led the way with the Best Pharmaceutical for Children Act (initiated in 2002) [101], which issues written requests to a company with regard to pediatric development, the incentive being additional exclusivity. This voluntary process is augmented by the Pediatric Research Equity Act (initiated 2003) [102], which can mandate studies in children when the same indication exists in adults. Europe has followed with the regulation of the European Parliament on medicinal products for pediatric use (EC) 1901/2006 [103,104]. The aim of the regulation was to increase the availability of safety information on drugs in children, without undue delay in licensing of drugs for adult indications. The regulation made a Pediatric Investigation Plan (PIP) mandatory for any new drug, at the end of the Phase I trials in adults and there was an incentive of an extension of 6 months to the patent for the relevant adult indication. However, both the US and European programs have allowed waivers based on adult disease indications and have failed to recognize the potential for the effectiveness of therapy when based on biology rather than tumor classification.

Risk and benefit from clinical trials in minors: Making the case for transparent and consistent publications

Rationale, aim and objectives: The European (EU) regulation on medicinal products for pediatric use (EC 1901/2006), which became effective in 2007, aimed to stimulate the clinical testing of medications in minors in order to reduce off-label use. In consequence, the number of minors taking part in randomized controlled clinical trials (RCTs) is likely to increase. Clinical trials in minors require a complex methodological design, a careful consideration of risks and benefits and a high level of ethical reflection. Unfortunately, as to the quality of clinical trials and their publications in minors little is known. Therefore, we assessed published reports of randomized, controlled clinical trials in minors, focusing on a common disease (asthma) and a defined spectrum of lifethreatening diseases (malignant diseases). Method: In an exploratory design, we scanned the publications for methodological aspects as well as indicators of ethical soundness, e.g., statements that informed consent had been obtained before the start of the trial or that a Data and Safety Monitoring Board ensured the patients’ safety during the trial. We also looked for passages reflecting the debate on equipoise or other forms of weighing risks and benefits. Results: We found that many of these aspects, which according to the scientific literature and generally acknowledged guidelines are essential to ensure good-quality trials and trial reports, were not considered in the publications analyzed. Conclusion: Therefore, we call for a more transparent and consistent presentation of the trials, especially of safety aspects, relying on a more critical and transparent ethical reflection.

Pflanzliche Arzneimittel für Kinder – Verbesserung der Datenlage

HERBAL MEDICINAL PRODUCTS FOR PAEDIATRIC USE: IMPROVING THE DATA BASECurrently there is scarcity of clinical data on herbal medicinal products for paediatric use. Due to this research gap and on the basis of HMPC’s (EMEA) evaluation, no herbal medicinal products for the age cohort 0-4 years could be made available in the foreseeable future. The objective of this article is to highlight possibilities of integrating the experience and knowledge of general practitioners and paediatricians in the application of herbal medicinal products as well as their structural sampling and processing. The author discusses the merits and shortcomings of observational and controlled retrospective studies and recommends the latter.

Drug development for children: how adequate is the current European ethical guidance?

It is unacceptable that many drugs prescribed to children have not been proven safe and effective for them. Yet some of the necessary drug studies do not directly benefit the...

Klinische Prüfung an Kindern im Spannungsfeld zwischen wissenschaftlichen Anforderungen, der Sicherstellung der korrekten Behandlung und ethischen Aspekten

Regulation (EC) No. 1901/2006 of the European Parliament and the Council dated 12 December 2008 on medicinal products for paediatric use is the result of a survey by the European Commission, concluding that children in the European Union are inadequately treated with medicinal products. The Regulation is addressed to the pharmaceutical industry with the intention to place medicinal products on the market and to the Member States to register all information on medicinal products for the treatment of children. The pharmaceutical industry will be obliged to conduct clinical trials in children for new medicinal products and medicinal products still under patent. This will be supported by incentives and rewards. As a consequence of the requirement to conduct clinical trials in children the framework and conditions have to be defined and ethical considerations have to be respected.

Off-Label Use of Prescription Drugs in Childhood and Adolescence

Not all drugs prescribed for children and adolescents are certified for use in these age groups. The present study describes the extent of off-label prescriptions in the outpatient sector and identifies deficits in the quality of product information. This analysis is based on patient-specific but pseudonymized drug prescription data for approximately 289,000 0- to 16-year-old members of the Gmünder Ersatzkasse, a German statutory health insurance provider, in the year 2002. For each substance prescribed, information regarding the youngest certified age group was derived from the product data. Of the 1,429,981 prescribed drug packages (726 active substances), 87.4% (66.1% of active substances) were prescribed in accordance with their license and 3.2% (15.7% of active substances) were prescribed off-label. For 9.4% of prescriptions (18.2% of active substances) the licensing status could not be established. For neonates and infants the proportion of licensed prescriptions was below average, at 42.5% and 82.8% of the prescribed packages (20.0% and 38.6% of active substances) respectively. After infancy, prescriptions were predominantly in accordance with licensed use. Deficits were seen in the indication groups "alimentary tract and metabolism," "respiratory system," "dermatologicals," and "sensory organs." The methodology enables characterization of off-label prescription and identification of fields where further research is needed. With regard to the EU regulation on medicinal products for pediatric use, this could assume increasing importance and contribute to the development of appropriate and safe medicines for children.

New paediatric research initiatives in the European Union

In contrast to the situation concerning adults, most medicines used to treat the children of Europe have not been tested on children and are not authorised for use in children. Therefore, the health and quality of life of children in the EU countries may suffer from a lack of testing and authorisation of medicines for their use. In particular, 46% of medicines prescribed to children in hospital are either unlicensed for their age group or, if they are, have been done so off-label [1]. Of the children who receive medication in hospital this figure rises to 67% [1], and in the context of intensive care up to 90% of paediatric medicines used are not licensed [2]. Although there may be concerns voiced about conducting trials in the paediatric population, this has to be balanced by the ethical concerns related to giving medicines to a population in which they have not been tested and therefore their effects, positive or negative, are unknown. The European Parliament and Council Regulation on Medicinal Products for Paediatric Use [3] aims to improve the health of the children of Europe by increasing the research, development and authorisation of medicines for use in children, and as such represents a major breakthrough in paediatrics research. Its policy objectives are: to increase the development of medicines for use in children; to ensure that medicines used to treat children are subject to high quality research; to ensure that medicines used to treat children are appropriately authorised for use in children; to improve the information available on the use of medicines in children; and to achieve the above while avoiding unnecessary studies in children. Ensuring that children have access to high-quality, effective and safe medicines, accompanied by high-quality information based on robust evidence, is crucial to giving children and their doctors the ability to make informed decisions about the treatment of disease and ensuring that the chosen medicines improve health. However, the diseases suffered by children often differ considerably from those suffered by adults, and the bodies of children tolerate drugs differently from those of adults. The dose of a medicine to treat a childhood disease cannot always be extrapolated from the adult dose: medicinal products used in the paediatric population have never been specifically studied or authorised (licensed) for use in that age group. This leaves no alternative for the prescriber than to use products off-label – i.e. the use

TEDDY EPMD: A European Paediatric Medicines Database

In line with European initiatives, TEDDY set up a new database, the European Paediatric Medicines Database, with the aim of creating a harmonised, integrated and reliable pan-European source of information. The data stored in the Database were the basis for examining the ‘state of the art’ of paediatric medicines licensed by the European Medicines Agency between October 1995 and December 2007. The results of the study show that 33% of medicinal products approved by the European Medicines Agency are intended for the paediatric population, and that this percentage has remained more or less constant in the 12 years of activity of the Agency. This trend is expected to increase rapidly in the future as a result of the adoption of the Paediatric Regulation. Nevertheless, it is essential that information on medicinal products for paediatric use are made publicly accessible and data should be verified and controllable. The European Medicines Agency has recently made public many information on medicines authorised in EU through the EudraPharm database. The TEDDY European Paediatric Medicines Database grants access also to information related to paediatric medicines, some of which are not available elsewhere. We deem this aspect a useful service to end users and a valid support to Regulatory Authorities.

Regulation (EC) No 1901/2006 on medicinal products for paediatric use &amp; clinical research in vulnerable populations

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:

European perspectives on pediatric formulations

Background: The 2007 European Union (EU) regulation on medicinal products for pediatric use may change the present unsatisfying situation in the EU by stimulating research and development of medicines for use in children through rewards and incentives.Objectives: This commentary reflects on the new EU regulations and guidelines, with special attention paid to the impact on pediatric formulation science. The focus of this article is on the EU perspective for pediatric formulations and highlights the differences compared with the pediatric drug formulation situation in the United States.Methods: Materials for this article were gathered during a literature search of MEDLINE and Chemical Abstracts (1970-October 2008) using the following terms: paediatric/pediatric drug formulations, age-appropriate dosage forms, child-appropriate medicines, and paediatric/pediatric regulation.Results: Since the EU legislation on medicines for children came into force in 2007, a great emphasis has been placed on creating new organizations, scientific networks, and programs dealing with pediatric medicines and child-appropriate drug formulations. Although the US legislation was an appropriate model, the EU introduced some novel measures to improve the current situation, such as the Paediatric Investigation Plan and the Paediatric Use Marketing Authorisation. For globally operating pharmaceutical companies, the peculiarities of the European market have a strong impact on their product development strategies. Because the European approach demands early investigations into drug formulations for children, various issues must be resolved, including the following: choosing formulations for each age group, determining which excipients may be used in the formulation and which delivery device is appropriate, and predicting the taste sensation of an oral formulation. Numerous initiatives and networks are evolving in Europe. An important future task will be the coordination of these activities and the linking to other groups working on pediatric formulations outside the EU.Conclusion: Similar to the research in pediatric drug formulations that was stimulated by the US legislation and incentives of the last decade, the 2007 EU legislation promises improvements in the availability of child-appropriate drugs in Europe.

Paradigmenwechsel in der pädiatrischen Arzneimittelanwendung

A short look at the history of paediatrics and pharmacology shows the existence for more than 100 years of the concept that children are not merely small adults but have their own specific pathology and physiology. Transferring adult pharmacology to children can produce considerable side effects and damage to the patients. With the entry into force of the European Regulation On Medicinal Products for Paediatric Use, the necessary change was made from empirical to more scientifically based and target-directed administration of paediatric medicines. Thorough personnel and structural changes are still needed, if the German paediatric and pharmaceutic industries are not to fall behind international standards: professionalism of conducting clinical drug trials in paediatric institutions, nets for multicenter drug trials and pharmacovigilance, inclusion of paediatric pharmacology in medical curricula and paediatric residency training, and intensified interdisciplinarity between the various medical disciplines as well as across boundaries of academical and industrial drug research.

Stem cell transplantation in children: how to design a new study

In contrast to adults, 50% or more of medicines used in children have never been actually studied in the paediatric population in the European Union community (EU). Under the impression that compliance with good clinical practice (GCP) requirements will lead to an improved quality of clinical trials, the ratification of the EU Directive 2001/20/EG now imposes the same GCP regulations demanded for commercial clinical trials on non-commercial trials or so-called investigator-initiated trials (IITs). Although it is desirable that all clinical trials comply with ICH-GCP, ensuring that an IIT conforms creates a significant burden for the principal investigator, turning an IIT into a substantial logistic, administrative and financial enterprise. This can only be achieved with a multidisciplinary approach, including physicians, statisticians, data managers, administrators and others. In particular, 'treatment optimization studies'--the most important clinical trials in paediatric oncology--are affected by this new law, potentially resulting in significant delays in the implementation of new and innovative treatment strategies in the paediatric population. This significant drawback was not foreseen but is now recognized and lead to measures to improve the situation for both non-commercial and paediatric clinical trials. Draft guidance on 'specific modalities for non-commercial trials', posted for comment last October, attempts to redress some of the research-crippling problems caused by the initial legislation; however, major problems remain. The EU regulation (EC) no. 1901/2006 'on medicinal products for paediatric use' was enacted in January 2007. This new regulation is a promising step in the right direction, as it will facilitate the development and accessibility of medicinal products specifically for use in children. To adapt to and benefit from this new situation and encourage IIT, a coordinated approach of high expertise is necessary to support and guide the novice in the field of IIT to successfully launch, conduct and complete clinical trials especially in children.

The EU-regulation on medicinal products for paediatric use

At present the EU-regulation on medicinal products for paediatric use is in the final legislation phase. The Regulation will bring essential changes to the policy of research with minors, to funding and to regulations of drug development in Europe. The article analyses contents of the regulation and possible effects on research with and treatment of mentally ill minors. The regulation seems to be a chance to improve pharmacological treatment for children and bring similar research conditions to Europe as they already exist in the US. Some terms of the regulation must be considered as critical due to vague definitions and ambiguously defined policies in some articles. The designated expert committee will be a powerful institution, but it remains to be seen whether this committee will act in the intended way. It is an existing and real danger that European child and adolescent psychiatry will be neglected by the new regulation, if there is no participation of scientists of this discipline in committees. The regulation makes it necessary for child and adolescent psychiatry to strengthen research in clinical trials and developmental psychopharmacology to get benefits from new legislation and improve health care for mentally ill minors.