Dr. Arinder Sihota, PhD

Drug Safety Manager

In December 2010, pharmacovigilance legislation was updated through amendments to Regulation (EC) No 726/2004 and Directive 2001/83/EC. This was followed by the addition of Commission Implementing Regulation (EU) No 520/2012 in June 2012. The main objective of these changes is to allow for better detection of new or changing safety issues, enabling rapid action to protect public health.

The main changes that have been brought about by these legislation amendments, and are effective from November 2017, are depicted in:

  • Updated Good Pharmacovigilance Practice, GvP Module VI, Management and Reporting of Adverse Reactions to Medicinal Products (currently in draft format)
  • Updated Good Pharmacovigilance Practice, GvP Module IX, Signal Management (currently in draft format)

Below we describe some of the key elements of the anticipated changes and action required for readiness.

Reporting of ICSRs in the EU to the EMA only, and removal of the interim arrangements

This intends to simplify reporting within the EU. The time taken to triage a case to determine its recipient(s), including competent authority specific identifiers in Eudravigilance, will decrease. In addition, Marketing Authorisation Holders (MAH’s) will no longer be required to carry out country specific registrations and/or testing in order to set up organisation identifiers.

Although it is expected that  reporting will in theory be simplified, it is advisable to obtain confirmation from competent authorities if any existing additional paper or portal reporting, should cease, or if this will be a continued national requirement. 

Receipt of all lCSRs from Eudravigilance in ISO ICSR E2B (R3) format only

MAHs can continue to submit ICSRs in E2B(R2) format, however, any cases downloaded from Eudravigilance will be in E2B(R3) format only. This of course requires system updates for compliance. MAH’s are advised to work with safety database providers to ensure full E2B R3 compatibility. A contingency plan should also be developed to ensure a validated conversion tool is available for use immediately should it be required, to ensure the readability of the files. 

Reporting of all non-serious EEA cases to EudraVigilance within 90-days of receipt

This will increase the burden of reporting. Currently only seven EEA NCAs require non-serious cases. The burden will vary by product and therefore per company and will inevitably demand extra resource for submissions via EVWeb.

Signal detection in the EudraVigilance Data Analysis System (EVDAS) and ICSR download functionality by MAHs

This will allow MAHs access to a greater level of detail on applicable ICSRs than is currently supplied. It will also mean that MAHs will become responsible for the regular review and analysis of the Eudravigilance database with regards to signal detection. 

The frequency of signal detection activities will depend on the nature of the product. For newly licensed products we expect a two weekly review cycle; for older, long-available products this may be stretched to six monthly reviews. The frequency should be documented and justified in signal management documentation.

MAH’s will have the option to create standard searches and there exists an ability to save customised searches within the system, however, depending on the nature of the product and the number of events this activity is likely to be resource intensive. From 01-Jun-2017, the EMA Registrations team will contact QPPVs to enable EVDAS user registration and access. 

Use of ISO IDMP terminologies, once available

As a consequence of the legal requirements set out in the legislation, the xEVPRM will be replaced by the ISO IDMP format. The use of these standards is mandated by the EU legislation (Commission Implementing Regulation (EU) No 520/2012). ISO IDMP format is an extension of the current information available in the xEVMPD.

In addition, some conceptual differences are introduced which will need to be taken into account while performing the data migration. Practically, there will be a phased implementation of ISO IDMP standards, termed SPOR (Substances, Products, Organizations, Referentials), allowing lessons learnt during each phase to be applied in subsequent phases. SPOR is expected to become mandatory from January 2018. 

The EMA have now announced a successful result from the independent EudraVigilance audit and a favourable recommendation from the PRAC, thus confirming that the EMA is on track, and the new EudraVigilance system is expected to be released 22 November 2017. Although we are still awaiting news on the GvP modules, and the exact changes described above and any others will only definitively be known once they are released in their final form. 

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Getting ready

Our expert cross-functional Pharmacovigilance Regulatory Change Management team is attending all relevant EMA stakeholder meetings and training to ensure we are aware of information, as it is released.  We are working on an intense implementation and roll-out plan and accordingly, are on track to have the extra resources, procedural updates, training and system changes in place in advance of the stipulated timelines. 

If you require assistance in understanding the new regulations and how they impact your business, we are available to support you and your business throughout the transition period. Contact us here.