Masterarbeit

Transition from the Extended Eudravigilance Medicinal Product Dictionary to the ISO standards for Identification of Medicinal Products – implications, challenges, and opportunities for pharmaceutical companies

Dr. Axel Hoffmann (2015)

Summary
Language: English
Article 57(2) of Regulation (EC) 726/2004 as amended by the provisions of Regulation (EU) No 1235/2010 and Regulation (EU) No 1027/2012, introduced the legal obligation that data on authorised medicinal products for human use in the EU/EEA must be submitted by pharmaceutical companies to the EMA. However, as required by Article 25 and 26 of Commission Implementing Regulation (EU) No 520/2012, the current Extended Eudravigilance Medicinal Product Report Message format is expected to be replaced in July 2016 by the implementation of the ISO Identification of Medicinal Product (IDMP) set of standards.
The ISO IDMP standards were developed in response to a worldwide demand for internationally harmonised specifications for medicinal products, and there aim is to facilitate the interoperability of systems in order to safeguard public health and to enhance global pharmacovigilance and risk management activities. As the implementation of the standards in the EEA is currently scheduled for 1 July 2016, this master’s thesis analyses the associated implications, challenges, and opportunities for pharmaceutical companies.
Development of common ISO guidelines and the EU regional guides is progressing and they are currently expected to be published around December 2015. The Agency is establishing a task force in order to develop and prepare a sound implementation road map for the EEA. However, the European Union is the only region that has a firm implementation date for ISO IDMP with a deadline of 1 July 2016 and is currently driving the ISO IDMP implementation activities. But other European countries will follow (e.g. Switzerland) and other ICH countries (US, Canada, and Japan) will also implement at some point.
With nearly a year left to meet the EU legislative requirements, pharmaceutical companies are challenged to develop an IDMP implementation approach to avoid non-compliance and fines. The common final ISO IDMP guidelines will not be published before December 2015 and thus it will be almost no option for companies to wait with the development of implementation strategies until the official regional guidance documents become available. If companies want to approach the IDMP compliance task in a strategic manner, they must act now. Therefore, this thesis delineates business requirements for the implementation of the ISO IDMP standards, potential approaches to achieve IDMP compliance, and their impact on current concepts of data management. The ISO IDMP standards with their global scope present an opportunity for pharmaceutical companies to establish a single, authoritative source of data and a master data management model for multiple purposes. By doing so, companies can improve the quality of their data, harmonise their IT data management systems, and achieve greater efficiencies across business units.
Pages: 50
Annexes: pages : 0