IDMP – Identification of Medicinal Products
ISO IDMP is a collection of ISO standards, which form the basis for a system of unique, global identification of medicinal products.
Beginning in mid 2016, all pharmaceutical companies with EU marketing authorization will be required to adhere to the new ISO standards.
The standards require information from many areas of the pharmaceutical business, including regulatory affairs, research and development, manufacturing and distribution.
Who is affected by IDMP?
- Regulatory affairs staff of pharmaceutical companies
- IT departments of medicines regulatory authorities, pharmaceutical companies, and service providers
- EU Qualified Persons responsible for Pharmacovigilance
- Pharmacovigilance staff of pharmaceutical companies and medicines regulatory authorities
- Medicinal product management software vendors
- Sponsors of clinical trials
Key Challenges of IDMP implementation
- Organizations must understand and deal with the complexity of where their data resides
- IDMP relevant information can be contained in various systems, which do not handle data in a uniform manner
- the majority of data required for IDMP is contained in unstructured format, e.g.
- Summary of Product Characteristics
- Pharmaceutical documents / CPC documents etc.
STRUCTURE THE UNSTRUCTURED
Information Discovery allows you to structure the unstructured information contained in various IDMP relevant sources
- Disease Status
- Undesirable Effects