EMA launches IDMP Implementation Guide
While clock now ticking for life sciences companies to comply with the new data standards, opportunities in the offing to simplify manufacturing and the supply chain
The European Medicines Agency (EMA) today published identification of medicinal products (IDMP) data standards that could potentially result in change and innovation in the life sciences—and provide the opportunity, some believe, to link the regulatory world with the supply chain world. Remco Munnik, the associate director at life sciences consultancy Iperion, has been working with the group creating the EU IDMP Implementation Guide version 2.0 (EU IG). Iperion will reveal what it believes are implications of the data standards for biopharma in a webinar on March 1.
The EU IG, covering the submission of data on medicinal products, sets out the implementation requirements of the International Organizations for Standardization (ISO) IDMP standards in the EU. The launch of the EU IG gets the clock ticking for life sciences companies doing business in the EU to start getting their data in order and processes in place. Further, the new Target Operating Model (TOM) signifies that existing processes need to be amended to collect more data at an earlier point in the current process.
In bridging the regulatory and supply chain worlds via the new data standards, Iperion contends that 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 sectors will be able to speak the same language, sharing data and terminology that will simplify manufacturing, supply chain and patient information data sharing, Iperion says.
