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

Regulatory Updates and Process Enhancements

• 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 [PDF, 4658 KB]

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