Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Submission of variations to implement changes in the product information texts following European Paediatric Work Sharing Procedures according to Article 45/46 of Regulation (EC) No 1901/2006 - from the point of view of a generic company ***

Anne-Kathrin Heese (Abschlußjahr: 2010)

Summary
Language: English
Whereas for the majority of the medicinal products used in adults sufficient and appropriate information is available, there is a lack of satisfactory information on medicinal products used to treat children within the European Union. At least fifty per cent of the medicinal products used to treat children's diseases, have not been authorised for paediatric indications and clinical trials in children have never been conducted. Therefore, medicinal products for the paediatric population are often used off-label. This common off-label use constitutes an substantial risk for children. Undesired side effects may occur as appropriate pharmaceutical formulations for children are often not obtainable. In addition, the desired efficacy might not be achieved due to inappropriate dosage of the respective medicinal product.
As a consequence of the missing information on medicinal products used in children within the European Union, the decision has been made to promote clinical trials in children in order to ameliorate the development of medicinal product for the paediatric population.
Finally, on 26 January 2007, the Regulation (EC) No 1901/2006 (The "Paediatric Regulation") was enforced after years of discussion regarding medicinal products for children.
The purpose of the Paediatric Regulation is to support the development of medicinal products for the paediatric population. The legislation engages pharmaceutical companies to conduct clinical trials in children. Marketing authorisation holders (MAHs) are obligated to conduct studies in accordance with a paediatric investigation plan (PIP), a research and development programme for the performance of clinical trials in children, and should present this data when applying for a new marketing authorisation. In return, MAHs might benefit from an additional six month patent protection period. It should be mentioned that for applications according to Article 10 and Article 10(a) of Directive 2001/83/EC, the applicant is not obliged to present data on clinical trials in children.
In addition, the enforcement of the Paediatric Regulation resulted in the creation of a European work sharing procedure for assessment of paediatric data has been established within the European Union. The purpose of this European paediatric assessment procedure is the evaluation of clinical trials conducted in children. Legal basis is given in Article 45/46 of the Paediatric Regulation. Whereas Article 45 describes an assessment procedure for new data on clinical trials in children for designated drug substances, Article 46 sets out the requirements for the submission of paediatric studies finished after 26 January 2007.
The purpose of the European paediatric work sharing procedure according to Article 45/46 of the Paediatric Regulation is to obtain information on conducted paediatric studies. Following the compilation and assessment of this data, the results are then added to the information texts (Summary of Product Characteristics and Package Leaflet) of the medicinal product in order to make the acquired information available for patients.
After finalising the work sharing procedure and publication of the respective European Public Assessment Report (EPAR), a variation to the marketing authorisation has to be applied for in order to implement the outcome of the work sharing procedure and amend the information texts (Summary of Product Characteristics and Package Leaflet) accordingly.
This master thesis sets out the legal basis of the European paediatric work sharing procedures according to Article 45/46 of the Paediatric Regulation. It describes the European work sharing assessment process and presents the type of variation to be submitted in order to amend the respective information texts (Summary of Product Characteristics and Package Leaflet). Medicinal products marketed by generic companies are usually not involved in the preceding work sharing procedure, however, the EPAR is also applicable for generic medicinal products.
That means that MAHs of medicinal products containing the same active substance as the originators brand also have to amend their marketing authorisations accordingly and submit a suitable text variation.
Pages: 38