The EU ISO IDMP Task Force meeting on 19th February, confirmed that IDMP is going to happen (we already knew that right?) through 2017-2018, leading to full and final implementation in 2019.
So far, the regulators have managed to release Iteration 1, which includes a list of agreed fields ready for the mapping between xEVMPD and IDMP. Despite the fact EMA has set its goal to have IDMP information ready by July 2016, we are far from that happening.
According to the last ISO IDMP Task Force meeting, all of the Implementation Guides (IG) and Standards are still under review. Most of the IGs are being prepared for publication at the earliest end of Q1 2017.
Below is a brief update from the last IRISS group meeting:
- Substance IG – 1st edition was published, 2nd edition (proteins, polymers herbals, homeopathic) is ready for ballot comments, 3rdedition (vaccines, allergens and advanced therapies) is being scheduled. Publication of the standard is delayed until Q2/Q3 2017.
- Vocabularies IG – ready for publication.
- Medicinal products IG – this will accompany the revised Standard when it goes to ballot in July/August. Publication of both documents is targeted for Q1 2017.
- Pharmaceutical products IG – same situation as the Medicinal products IG.
- Core Principles for Maintenance and Identification of Terms – looking to send this to ballot after the November meeting and publish mid-2017.
- EU and FDA are working together in harmonizing the GSRS systems – the goal is to map everything with one code for substances across all regions.