As our life is strongly influenced by the fast growth of the pharmaceutical industry, there is an urgent need for control of their products. Safety of drugs available on the market depends on proper reporting procedures of any adverse drug reactions or effects, even if only suspected.
The European Union (EU) legislation regulates requirements for electronic safety reporting in EudraVigilance data processing network, through establishment of the following: Regulation (EC) No 726/2004, Directive 2001/83/EC as amended, and Directive 2001/20/EC. The EudraVigilance was developed by EMA in compliance with two standards developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): ICH E2B (R2) (‘Maintenance of the ICH guideline on clinical safety data management: data elements for transmission of Individual Case Safety Reports) and ICH M2 (‘Electronic Transmission of Individual Case Safety Reports Message Specification’).
The European Medicines Agency (EMA) is making efforts to secure the highest quality and safety of medicines. As a result of co-operation between EMA and Heads of Medicines Agencies (HMA), the new ‘EU Individual Case Safety Report (ICSR) Implementation Guide’ was finalised in July 2013, and published in January 2015. However, it will take effect only on the 1st of July 2016. The new guide will support the implementation of a new international standard for safety monitoring of medicines. The EU Member States will work hard to prepare for the use of this standard, which is considered to be helpful to pharmaceutical industry and regulatory authorities. The ICH guideline concerning pharmacovigilance (PhV) practices will adequately reflect current safety reporting standards. To assure this, the refreshed ICH PhV standards are going to be compliant with the International Organization for Standarization (ISO) ICSR normative act: EN ISO 27953-2:2011 Health Informatics, Individual case safety reports (ICSRs) in pharmacovigilance — Part 2: Human pharmaceutical reporting requirements for ICSR (ISO 27953-2:2011).
The new guideline is considered to improve reporting of suspected side effects of medicines in one compatible format of Individual Case Safety Reports (ICSRs), and therefore it is also called ISO ICSR. The ISO ICSR aims to establish the same practice and format of reports on individual cases of suspected side effects in patients due to a medicine across the whole world. In addition, information on adverse drug reaction as well as therapeutic uses of medicines is believed to be of a higher quality by unifying procedures of safety reporting.
The protection of personal data is also addressed in the new EMA standard, as it refers to better protection of individual records included in ICRSs prepared by pharmaceutical companies as well as regulatory authorities. Furthermore, the time for detection and addressing safety issues will be much shorter than it is now according to the requirements of the ISO ICSR. Overall, the new regulation seems to set up the golden standard for safety reporting.
The ISO ICSR outlines content and format of safety reports that shall be transmitted electronically, as well as it defines rules for validation of the reports and classification of data quality principles. The guide will be a useful tool for IT developers for programming and creation of new software or development of pharmacovigilance databases.
The establishment of ISO ICSR guidelines is a big step towards enhancement of the EudraVigilance system, which includes information on safety of medicines from the entire European Economic Area (EEA). As the ISO ICSR standard will be available in specific regions, it is important that additional data elements that reveal local requirements are included in the document. This will be crucial to generate valid ICSRs from different parts of the EEA. Valid reports will be referred to as Safety Messages, and the confirmation of the properly finalised reports – as Message Acknowledgements.
As the ISO ICSRs guideline introduces the Electronic Data Interchange (EDI) process based on the exchange of electronic messages concerning safety, it is important to develop effective project tools so that they assure proper reporting through the new system. The Sender shall receive appropriate confirmation of the completeness of the EDI process initiated by Safety Message. The ISO ICSR standard includes a description of the responsibilities of all involved parties to help monitor proper actions during communication, and adherence to reporting processes.
The new PhV reporting practices will require appropriate technical solutions, which will contribute to the improvement of reported safety information.