Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Harmonisation of Product Information Texts of Generic Medicinal Products in EU – And its Impact on the Necessity of User Testing and Bridging

Hanna Bölke (Abschlußjahr: 2010)

Language: English

Harmonisation of the structure of product information started with introduction of the summary of product characteristics as a final position document at the end of the assessment process for new applications. However, the harmonisation of the content of product information texts throughout the EEA had its beginning with introduction of common procedures in 1995. Centrally authorised products had completely harmonised product information throughout the EEA since then. MAs reached via MRP until 2005 had harmonised SmPCs only.

Due to the review of legislation in 2005 this harmonisation got a stronger focus. The product information texts, SmPC, PL and labelling, became part of all common procedures CP, DCP and MRP. That meant that all product information texts available in the EEA shall be based on the English version which has been agreed during the common procedure. After the closure of the procedure exact translations have to be created in all national languages. The background of this harmonisation is that in all countries of the EEA shall be given the same information for equivalent products.

Generic medicinal products are intended to be equivalent to their reference product. The applicant of a generic has to create his product information based on those ones available from the reference product. Since the harmonisation of product information texts of reference products varies for the different products depending from the procedure of their authorisation the applicant of a generic has to pay attention on several aspects. His text versions have to comply with the current EU legislation and deduced guidance documents but have also to be conform with the originators text versions.

User testing of package leaflets has been introduced to improve PLs and demonstrate that they are legible, easy to use and understandable for the target group. This target group is represented by the patients taking the medicine or their carers. With an adequate questionnaire the PL is tested on a carefully selected group of testers. Between different rounds of testing the applicant shall revise the PL to optimise it until the criteria for a successful user test can be met.

Harmonisation of product information texts, especially in case of the PL, and the necessity of user testing are two issues of close relation. The more harmonised the text versions of products containing the same active substance are throughout the EEA the less should be required user test reports for each new application for an equivalent product. Nowadays one version of a PL often is tested various times by different applicants and MAHs due to the lack of information whether the harmonised text of the reference product is already user tested and the report considered acceptable by at least one agency. Thus transparency on the information whether a harmonised text is positively user tested would be desirable. Furthermore should the inclusion of user testing into harmonisation processes get a stronger focus. A harmonised text which is not user tested might be useless and the need for applicants to test it can lead again to disharmonisation.

It can be concluded that within the last years there has already been done a lot of improvement regarding harmonisation within the EEA but there is still a huge space for further improvement.

Pages: 35