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 training materials for NCA (read-only) users of EU-SRS, and publish in the HMA – SVG site along with the guides
    
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

• Substance experts from AT, CZ, DE-PEI, DE-BfArM, DK, ES, FI, FR-ANSES, FR-ASNM, NL, and NO are part of different groups
• Representatives from other agencies new and previous participants,  are welcome to join in the groups.
• 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: Trygve Ottersen, NoMA, NO
• Secretary: Vacant postion
• Meeting cycle: one two-days face-to-face meeting, one two-half day online per year. Regular teleconference meetings, including bi-weekly status meetings technical meetings, and SVG1, SVG2 and SVG3 group meetings.

SVG secretary

E-mail: svgnoSpam@noSpamhmanoSpam.eu

General documents
 

• General EU-SRS user guide, version 2.0
• EU-SRS Read-Only guide, version 1.0
• EU-SRS Chemicals guide, version 1.0
• EU-SRS Polymers guide, version 2.0
• EU-SRS Proteins guide, version 2.0
• EU-SRS Mixtures guide, version 2.0
• EU-SRS Homoeopathics guide, version 1.0
• EU-SRS Human Vaccines guide, version 1.0
• EU-SRS Veterinary Vaccines guide, version 2.0
• EU-SRS Herbal Substances guide 1.0

Newsletter
 

• EU-SRS updates - January 2025

Call for Expression of Interest for SVG Secretariat

Identified tasks of SVG Secretariat: 
 

• Organizing and hosting any Team meeting F2f, online in EU and transatlantic
• Support in software testing, when needed
• Maintain SVG-SRS mailbox, allocate emails to the relevant SVG group
• Liaise with NCA’s on EU-SRS matters
• Maintain the HMA SVG Working group website
• Stakeholder contact 

SVG Secretariat – competency profile:
 

• Excellent organizational skills
• Organizational sensitivity
• Excellent communication skills, writing and verbal (English)
• Presentation skills
• Higher education (e.g. bachelor, university or similar degree)
• Ms Office skills (Excel, PowerPoint, SharePoint)

Skills to be learned on-the-job, if not yet available:
 

• Basic understanding of ISO-IDMP, or affinity with standardization topics
• SPOR, including SMS in relation with EU-SRS
• EU-SRS in relation to GSRS
• Working process in the validation of substances in the SRS instances
• EU-SRS: use of CV’s, User rights, database validation rules