HMA Substances Validation Group
The HMA Substances Validation Group (SVG) has the following tasks:
- 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
- Maintain and publish substances management guidance documentation
- Maintain and publish training materials for NCA (read-only) users of EU-SRS, in cooperation with the EU NTC
- Support NCA’s and NCA staff with using EU-SRS and extracting data from EU-SRS, either by releasing learning materials or direct support
- 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
- 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
- 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
E-mail: a.rozema@ cbg-meb .nl