MAA short for Marketing Authorization Application
Marketing Authorisation Holder (MAH)
Master Data Management (MDM) is critical for IDMP compliance
In matching IDMP´s required data with customer´s data there will be several systems identified which hold IDMP relevant data.
In case of Marketing Authorisation Holders (MAHs) this will be Regulatory Information Systems (RIMs) which must be focused on. The RIM will be source for most of regulatory input, partly for substances, marketing and a small part of the packaging data. But more details may be needed from other systems.
Master Data Management will help assembling these data from the different sources, augmenting them by further data, preparing them for submission and matching the internaly used vocabularies against IDMP´s controlled dictionaries.
What impact will IDMP have on Providers of Structured Drug Information Systems?
IDMP will not only become standard for regulatory purposes. Furthermore it will also become the standard model used for systems in Pharmaceutical Information Systems, Drug Dictionaries, Clinical Decision Support, Hospital Information and Patient Information. So the impact of IDMP on providers of such systems is significant!
What are the key steps of a gap analysis and which next steps should be done?
It is important to create a common understanding for the project across the company. So typically all departments should be involved. The steps could be:
- Identify on a very high level the data sources and the owners that are candidates for extraction of idmp required data
- Define some test products which offers variations in product type, substances (mono, combi with different strength), in-licensed products etc., to be encoded and structured in IDMP
- Extract the required data manually out of the identified sources (step 1) and check if all needed information is available. Classify the quality of the extracted data in effort categories such as:
a. single source which can be mapped to IDMP
b. single source which requires significant effort to format data for mapping to IDMP
c. available in multiple systems requiring harmonisation, or with poor data quality
d. unstructured Data (Documentation)
e. location not found; substantial manual effort to retrieve information
- Define (based on the outcome of step 3) your user requirements and potential high-level solution architecture. This can vary from an inhouse solution up to a wide range of solution scenarios with or without an integrated Master Data Management system
- The final step is the Request For Proposal (RFP) and the vendor selection and implementation
How can IDMP1 help you make your IDMP project a success?
The ISO IDMP standard will not only be the standard for regulatory affairs, but it will also become the standard model for pharmaceutical information systems used in in public information systems for patients, in clinical decision support in hospitals and in e-health.
IDMP1 offers structured data for medicinal products mapped against the IDMP´s required structure and controlled vocabularies. Its IDMP Drug Dictionary is an excellent starting point to define the structured representation of S(m)PC documents´content (e.g. for clinical particulars).
Medical Dictionary for Regulatory Activities (MedDRA)