Guidance on the Identification of Medicinal Products
![Bioburden - Live Online Training](files/eca/userImages/training.img/Z-ECA-Bioburden-LOT.jpg)
Recommendation
15/16 October 2024
Regulatory Expectations and Practical Experiences
This guidance, published in March, is aimed at all persons involved in the submission of medicinal product data. It supports the development and implementation of the International Organization for Standardization (ISO) drug identification standards (IDMPs) for substances, terminologies and other information used throughout the medicinal product development life cycle worldwide. The aim of these standards is to make the international exchange of medicines information between stakeholders more accurate, complete and consistent.
The five IDMP standards and associated technical specifications were developed within the member organisations of the ISO network. Originally published by ISO in 2012, the standards provide a framework for unambiguously identifying and describing medicines with consistent documentation and terminology to enable reliable exchange of product information between regulators, manufacturers, suppliers and distributors worldwide. This framework includes data models, terms and definitions.
The guidance also explains the FDA's position and progress in harmonising the agency's standards with IDMP standards. FDA supports these standards for identifying and describing marketed non-investigational drugs with the goal of harmonising standards for the international exchange of medicinal product data. The documents should only be considered as a recommendation and not a guideline.
For more information, see the FDA Guidance "Identification of Medicinal Products - Implementation and Use".
Related GMP News
29.05.2024New FDA Draft Guideline regarding the Use of Human- and Animal-derived Materials
22.05.2024New FDA Draft Guideline regarding Safety Testing of human allogeneic Cells
07.05.2024Final Approval of SoHO Regulation
07.05.2024FDA Warning Letter to a Biotechnology Company in China
07.05.2024Update of Guideline on Epidemiological Data
05.03.2024FDA Warning Letter on misbranded and unapproved Drugs