EU-SRS provides scientifically sound descriptions of substances used in medicinal products in the EU by applying regulatory standards for the identification of medicinal substances in accordance with the ISO IDMP standards. This is a core central element for the identification of medicinal products.
The system release date has now been set at 30 September 2021. Strategies are worked out to ensure sufficient substance expert resources will be available to meet this deadline.
The updated strategy was presented to various stakeholders (EU-SRS community, the EU-SRS Steering Committee and the Heads of Medicines Agencies). HMA endorsement this release strategy on November 26.
The EU-SRS system will be installed, validated and made available for the European medicines regulatory network. The end of the data cleansing remains foreseen to be completed in 2022. Relevant documents can be found in the resources section of the UNICOM website. Documents published are, for example, the “substance data cleansing guide” and an overview with outcomes of the data cleansing efforts.