The latest regulations for human and veterinary medicinal products, as well as medical devices, include the mandate to set up databases with detailed information about available products. These databases must be realized and implemented in the near future, and require a concerted effort now if tangible real-world benefits are to follow.
An article of Associate Director Remco Munnik is published on the website medtechintelligence.com on 29 January 2020.
Capitalizing on Standardized International Product Data
Substantial effort and investment have gone into preparations for new regulatory requirements around medicinal and medical products, including ISO IDMP (identification of medicinal products) standards and the EU’s Medical Device Regulation (MDR) and the New Veterinary Regulation (NVR). It is a shame, then, that we are not further along in harnessing these developments for real-world gain. So, in 2020, focus and ambition should turn back to where it is needed: On the higher purpose of such initiatives, and the innovation and improved patient experience they are designed to elicit—rather than on the intricate logistical details and deadlines that are still being ironed out by regional regulators.Read the full article
Remco Munnik is Associate Director of Iperion Life Sciences Consultancy, with over 20 years of experience in Regulatory Affairs, with a special focus on Global submission procedures, electronic submission (eCTD) and regulatory data management (xEVMPD, ISO IDMP and RIMS). He has worked at both pharmaceutical industry and consultancy. In addition, Remco has been directly involved in the development and roll-out of the EU Telematics environment and has in-depth knowledge of the systems. Remco is member of the EMA ISO IDMP Taskforce Product & Organisation group.