EMA publishes IDMP data standards – our top 5 takeaways

EMA publishes IDMP data standards – our top five takeaways

Today the European Medicines Agency (EMA) has published IDMP data standards that will drive change and innovation in the life sciences sector.

The EU IDMP Implementation Guide version 2.0 (EU IG) – covering the submission of data on medicinal products – sets out the implementation requirements of the ISO IDMP standards in the EU. The launch of the EU IG sets the clock ticking for life sciences companies doing business in the EU to start getting their data in order and processes in place. Additionally, the new Target Operating Model (TOM) will mean that existing processes need to be amended to collect more data and at an earlier point in the current process.

Speaking the same language

The new data standards provide the opportunity to link the regulatory world with the supply chain world. Until now, the supply chain, regulatory, pharmacovigilance, and clinical functions might all use different names for the same products and active substance(s). Now these different worlds will be able to speak the same language, sharing data and terminology that will simplify manufacturing, supply chain and patient information data sharing.

Compliance with ISO IDMP will provide an opportunity as well as a being a regulatory exercise. Standardised data will drive more efficient processes. Beyond that, standardisation will support fresh and innovative ways of sharing data and automation across the regulatory and supply chain divide. Life sciences companies will be able to use this to gain competitive advantage.

As the world watches the fast roll-out of the coronavirus vaccine, unnecessary delay is no longer acceptable. In parallel with the launch of the EU IG version 2.0, the sector’s response to the pandemic has further highlighted the pressing need for data standards – so that data may be shared to report on supply chain issues, which vaccines are administered to which patients, adverse events and for patient information.

Remco Munnik, Associate Director at Iperion, has been working with the group creating the EU IG. Commenting on the publication, he said: “At Iperion we are proud to have worked closely with the regulator to help steer the development of these major standards and we are delighted to see IDMP version 2 come to fruition right on schedule.”

Top 5 takeaways

Here, Remco shares his top 5 takeaways from the publication for Pharmafield:

  1. Life sciences companies doing business in the EU need to start getting their data in order and processes in place. Additionally, the new Target Operating Model (TOM) will mean that existing processes need to be amended to collect more data and at an earlier point in the current process.

 

  1. The SPOR Target Operating Model (TOM) will become a foundational building block for IDMP compliance – and improving patient information. The ISO IDMP standards are based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organisation and referential (SPOR) data. Life sciences companies now need to accelerate their preparations towards SPOR-readiness.

 

  1. The new data standards provide the opportunity to link the regulatory world with the supply chain world. Until now, the supply chain, regulatory, pharmacovigilance, and clinical functions might all use different names for the same products and active substance(s). Now these different worlds will be able to speak the same language, sharing data and terminology that will simplify manufacturing, supply chain and patient information data sharing.

 

  1. Compliance with ISO IDMP is an opportunity as well as a regulatory exercise. Standardised data will drive more efficient processes. Beyond that, standardisation will support fresh and innovative ways of sharing data and automation across the regulatory and supply chain divide. Life sciences companies will use this to gain competitive advantage.

 

  1. Delay created by poor data sharing is no longer inevitable or acceptable. As the world watches the fast roll-out of the coronavirus vaccine, unnecessary delay is no longer acceptable. In parallel with the launch of the EU IG version 2, the sector’s response to the pandemic has further highlighted the pressing need for data standards – so that data may be shared to report on supply chain issues, which vaccines are administered to which patients, adverse events and for patient information.

Remco Munnik is Associate Director at Iperion Life Sciences Consultancy. Go to www.iperion.com