Mandatory Use of ISO ICSR/ICH E2B(R3) and EDQM Terminology for Dosage Forms (DF) and Routes of Administration (RoA)

On 3 February 2022 the EMA published guidance on the mandatory use of ISO ICSR/ICH E2B(R3) and EDQM Terminology for DF and RoA.

The new EudraVigilance system launched in November 2017 supports the submission and analysis of reports of suspected adverse reactions in the pre- and post-authorization phase based on the International Organization for Standardization (ISO) Individual Case Safety Report (ICSR) standard – ISO 27953-2.

The use of the ISO Individual Case Safety Report (ICSR) format is set out in Article 26(2)(a) of the Commission Implementing Regulation (EU) No 520/20122 and the modalities on how to implement and apply the ISO ICSR standard are defined in the ICH E2B(R3) documentation.

Additionally, ICH E2B has agreed5 to use the ISO standard terminology on pharmaceutical dose forms and routes of administration6 as set out in Article 25(f)(1) of Commission Implementing Regulation (EU) No 520/2012.

Following a transitional period and consultation with the relevant stakeholders, the EMA Management Board announced in December 2019 that ISO ICSR standard and the Individual Case Safety Report standard and the ISO terminology on pharmaceutical dose forms and routes of administration maintained by EDQM should be implemented by all the stakeholders by 30th June 20227 in relation to reporting obligations to EudraVigilance (pre-and post-authorization).

This change management document describes the activities performed by the EMA to support the stakeholders during the implementation of the above-mentioned standards.

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