HMA Substances Validation Group


The HMA Substances Validation Group (SVG) has the following tasks:

  1. On behalf of HMA, maintain substances data in the European Substance Registration System (EU-SRS), containing scientific substance information.
    • Analyse the available substances data, available in regulatory documentation as well as in public databases such as G-SRS or Scifinder.
    • Register, validate and approve substances data
    • Update substances data when new information is available
    • Ensure ISO IDMP compliance of data
    • Provide feedback to the EMA SMS team in case of necessary changes on substances data in SMS
  2. Maintain and publish substances management guidance documentation
  3. Maintain and publish training materials for NCA (read-only) users of EU-SRS, in cooperation with the EU NTC
  4. Support NCA’s and NCA staff with using EU-SRS and extracting data from EU-SRS, either by releasing learning materials or direct support
  5. Liaise with HMA as well as other expert groups / `regulatory´ groups, associations from interested parties or stakeholders, including but not limited to:
    • EMA SMS team
    • FDA/NCATS team
    • HMA working groups such as CMDh, CMDv, HMPWG
    • EDQM
    • European Commission
    • EMA’s committees and working parties such as CHMP, CVMP, HMPC, BWP, QWP
    • IWP (immunologicals working party)
    • NCA EU-SRS users
    • Kew Gardens
    • WHO
  6. Current three SVG groups are implemented as corresponding `sub-working groups´ (covering both Human and Veterinary substances):
    • SVG1, covering Chemicals, Polymers, Mixtures, SSG1
    • SVG2, covering Proteins, ATMPs, Nucleic Acids, Vaccines, Blood Products
    • SVG3, covering Homoeopathics and Herbals

Members and Representatives

  • The steering group is composed of substance experts from AT, CZ, DE-PEI, DE-BfArM, ES, FI, FR-ANSES, FR-ASNM, IT, NL, SE and NO.
  • Representatives from other agencies may be added.
  • The group includes guest membership of WHO-UMC (no access to EU-SRS).
  • Chair: Marcel Hoefnagel, CBG-MEB, NL
  • Vice-chair: Bjørg Overby, NoMA, NO
  • Mentor: Audun Hågå, NoMA, NO
  • Meeting cycle: 1-2 face-to-face meetings per year as well as regular teleconference meetings, including bi-weekly status meetings and SVG1, SVG2 and SVG3 group meetings


Annet Rozema, CBG-MEB, NL

Key Documents