MakroCare IDMP Consulting Services
European Union legislation is driving Identification of medicinal product implementation. The commission implementing regulation specifies that ISO (International organization for standardization) standards will be used to lay down foundation of IDMP and implementation sunrise date is July 2016.
European Union regulators have very clearly mentioned their intention and expectation about IDMP which will be simply beyond capturing data pertaining to registration and submission but entire regulatory activity gamut (development, registration and life cycle management of medicinal products; pharmacovigilance and risk management).
In accordance with EU, EMA is working with Regulatory experts, Industry experts, numerous other competent committees and authorities to rightfully define the requirement for data stipulation that will also facilitate following area such as clinical trials, pediatric areas, scientific advisory and quality.
ISO IDMP implementation road map must focus following key considerations:
- Gap analysis
- Migration Analysis
- Implementation plan
IDMP implementation will influence Pharmacovigilance legislation requirements, along with it following areas as well:
- ICSRs – Submission/use of IDMP data in the ICSR
- xEVMPD – Submission/Migration of IDMP data and the implementation /adoption of controlled vocabularies
- Regulatory Submissions (eCTD/NeeS-addition of IDMP components within Module 1
- EudraCT and Clinical Trial Portal and Database as introduced by Articles 80 & 81 of Regulation (EU) No 536/2014iii
- Serialisation as introduced by Directive 2011/62/EUiv(Falsified Medicines Directive)