Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Electronic submission of information on medicinal products authorized in the European Economic Area according to Article 57(2) of the Regulation (EC) No 726/2004 and the challenges of the XEVMPD ***

Erika Henkel (Abschlußjahr: 2015)

Summary
Language: English
One of the important initiatives resulting from the new pharmacovigilance legislation, which started to become applicable from July 2012, is the collection of key information on medicinal products authorized in the EU. The legal basis for the submission of these information by MAHs holding marketing authorizations in the EU is Article 57(2) of "Regulation (EC) No 726/2004", as amended". On 28 May 2014, also the EEA countries outside EU have been integrated into the pharmacovigilance legislation. Consequently, MAHs of medicinal products authorized in the EEA countries outside the EU are also required to comply with requirements according to Article 57(2) of "Regulation (EC) No 726/2004, as amended". The main purposes of the collected data are to facilitate regulatory decisions and to strengthen regulatory information flow and communication. Additionally, the use of internationally accepted standard terminologies facilitates the sharing of regulatory data and contributes to the improvement of quality of shared information throughout all parties in the EEA affected by pharmacovigilance. The 2 July 2012 was the deadline for MAHs to enter information on their medicinal products into the current applicable inventory XEVMPD by using the XEVPRM format published on 5 March 2012. A number of unclear business rules and the short timeframe between the published format and the following deadline for submission, however, resulted in a high amount of incorrect and duplicate data submitted into XEVMPD. Thus, the EMA has identified the need to enhance the quality of data in XEVMPD. Since 2 July 2012, the EMA has published a number of amendments regarding the XEVPRM messaging schema, business rules and controlled vocabularies. The EMA intended to start using the Article 57 data from the end of the first quarter of 2015. However, because of the not yet known number of non-compliant MAHs or not finalized quality control processes, this will be delayed. Furthermore, based on mistakes made by the implementation of XEVMPD, the EMA has started a number of initiatives to effectively plan, develop and implement the future project of ISO IDMP such as the establishment of the ISO IDMP Task Force. Nonetheless, the implementation of ISO IDMP into everyday practice will certainly be a challenge for all involved parties at least due to the overall complexity of the project. Issues, such as the integration into existing local systems, smooth transition from XEVMPD or the early publishing of implementation guidelines to hold the deadline  of 1 July 2016, need to be properly handled. After that, affected parties can fully benefit from its advantages (such as the improvement of data integrity or the enhancement of operational or regulatory processes between all stakeholders).
Pages: 48