NEX2US Newsletter Issue 11 | May 2025

Topics

Regulatory Updates and Process Enhancements

Therapeutic Products

  • New Online Tools Launched: Application Timeline Calculator and Cloud-based Platform for Dossier Submission
  • Release of SG-HSA Specification Package (v1.0) for eCTD Implementation in Singapore
  • Pilot Programme Launched to Extend E-labelling to Pharmacy only (P) and General Sale List (GSL) Therapeutic Products (TP)
  • Update of Guidance on Therapeutic Product Registration
  • Clarification on Criteria for Expediated Review of Pending MIV Applications
  • Implemented GMP Requirements for Chemical DS Manufacturers 

Medical Devices

  • Change Management Program (CMP) for Software as Medical Device (SaMD)
  • Milestone in Patient Safety: Phase 2 of Implementation of Unique Device Identifier (UDI) system in Singapore
  • Supporting Digital Health Product Innovation

Cell, Tissue and Gene Therapy Products (CTGTP)

  • "SHARE": One-Stop Digital Portal for CTGTP Dealer’s Notice, Class 1 CTGTP Notification and Class 2 CTGTP Registration
  • Streamlining Access to CTGTP Information

Clinical Trials and Innovation Office

  • Formalisation of the Innovation Office
  • Upcoming Implementation of the Principles and Annex 1 of the revised ICH E6 (R3) Guideline on Good Clinical Practice (GCP) 

Therapeutic Products and Cell, Tissue and Gene Therapy Products

  • Launch of new Risk Management Plan webpage (1 April 2024) – with implementation of new online form for safety notifications and revised interactive Singapore-Specific Annex (SSA)

International Collaboration

  • Access Consortium
  • Project Orbis
  • HSA Signs Memorandum of Understanding with the Ministry of Health, Malaysia
  • Introduction of Swissmedic as HSA’s reference agency
  • Regulatory Leverage

News and Engagements

  • Next Generation Medical Devices (NextGen MD) Initiative Webinar
  • More than 40 under probe after multi-agency raid in Geylang on illegal and vice activities
  • Good Submission Practice Workshop
  • Industry Training Workshop on (i) Product Defect Reporting and Recall Procedures, and (ii) Management of Nitrosamine Impurities in Therapeutic Products
  • Complementary Health Products Training Workshop
  • HSA Removes Over 3,000 Online Listings of Illegal Health Products in First Joint Operation with Online Platforms
  • Engaging clinical trial stakeholders on ICH E6 (R3) Good Clinical Practice (GCP) Guidelines

Click on the link below to download the issue in pdf:

NEX2US Issue 11

Industry member, Cell, Tissue and Gene Therapy Products, Chinese Proprietary Medicines, Controlled drugs, psychotropic substances and poisons, Cosmetic products, Health supplements, Medical devices, Therapeutic Products, Traditional medicines
Published:

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NEX2US Newsletters

20 May 2025