The identification of medicinal products consists in a series of standards that were created by the International Organization for Standardization (ISO) to provide standardized medicinal products identification to improve drug safety. Implementation is starting with EMA and FDA should follow very soon.
IDMP is worldwide standard that will require to provide nearly twice more data pre and post marketing than European Article 57 (xEVMPD).
Those data come from different functions (PV, Regulatory, Clinical, Supply Chain, Industrial Affairs…), managed in several and heterogeneous sources (databases, documents, spreadsheets, etc.…).
Its implementation requires a clear strategy, based on cross-functional approach and impacting multiple information management systems.
Timelines are aggressive and iterated implementation asked by the agency requires agility.
Marketing-authorisation holders (MAHs) of medicines authorised in the European Union (EU) and European Economic Area (EEA) must submit information on these medicines to the European Medicines Agency (EMA) and must keep this information up-to-date.
The International Organisation for Standardisation (ISO), Identification of Medicinal Products (IDMP) standards specify the use of standardised definitions for the identification and description of medicinal products for human use.