NEX2US Newsletter Issue 10 | April 2024

Topics

International Recognition

  • HSA Singapore Designated as WHO-Listed Authority for its Medicines Regulatory System
  • HSA's Stringent Regulatory Authority (SRA) Status for In-Vitro Diagnostic Medical Devices (IVD) Regulatory Updates and Process Enhancements
  • HSA and Ministry of Food and Drug Safety (MFDS), Republic of Korea (ROK), Signed Mutual Recognition Agreement (MRA) on Good Manufacturing Practice for Medicinal Products
  • Implementation of GMP Evidence for Drug Substance Manufacturers
  • Update of Guidance Documents for Therapeutic Product Registration and PRISM Application Form
  • Implementation of Electronic Common Technical Document (eCTD) in Singapore
  • Introducing "SHARE" - Your digital portal for CTGTP Dealer's Notice and Product Notification
  • Cell, Tissue and Gene Therapy Product (CTGTP) Classification Tool
  • New Webpage on Duties and Obligations of CTGTP Registrants, Manufacturers, Importers and Suppliers
  • Advancing Guidance on Clinical Evaluation: Real-World Evidence and Software Medical Device Evaluation
  • Milestone in Patient Safety: Phase 2 of Implementation of Unique Device Identifier (UDI) system in Singapore
  • Accreditation of ISO13485 Certification - Requirements for Medical Device Dealers
  • Enhancements in Risk Classification for In-vitro Diagnostic Medical Devices and Updated Tools
  • Revised Qualification Criteria for Immediate and Expedited Evaluation Routes for Medical Device Product Registration
  • Advancing Standards - HSA's Incorporation of IMDRF Recommendations for Software in Submission 
  • Phase 2 of Voluntary Notification of Health Supplements and Traditional Medicines 
  • New Guidance for Reporting of Adverse Effects, Products Defects and Product Recalls for Cosmetic Products
  • Implementation of Active Ingredients Regulations

International and Bilateral Collaborations

  • Access Consortium offers pipeline meetings to pharmaceutical and biotechnology companies
  • Access Consortium Promise Pilot Pathway
  • Advanced Therapy Medicinal Products Working Group (ATMP WG)
  • Expression of Interest for Access work sharing initiatives for New Active Substances, Generics and Biosimilars
  • The Thirty-Eighth Meeting of the ASEAN Cosmetic Committee and its Related Meetings
  • Permanent Forum on International Pharmaceutical Crime (PFIPC) and International Laboratory Forum on Counterfeit Medicines (ILFCM)
  • HSA approvals recognised by MHRA’s new International Recognition Procedure for medicines
  • HSA’s medical device marketing approval accepted for support of compliance by Hong Kong

News and Engagements

  • Public Consultation on the Proposed Amendments to the Health Products (Therapeutic Products) Regulations
  • Complementary Health Products (CHP) Industry Training Workshop
  • Public Webinar on draft E6 (R3) Good Clinical Practice guideline 
  • Industry briefing session on implementation of eCTD in Singapore

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

NEX2US Issue 10

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


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