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Health Sciences Authority
NEX2US Newsletters

NEX2US Newsletter Issue 08 | January 2022

Audiences

Industry member

Product type

Cell, Tissue and Gene Therapy Products

Chinese Proprietary Medicines

Controlled drugs

Cosmetic products

Health supplements

Homeopathic medicines

Medical devices

Psychotropic substances and poisons

Therapeutic Products

Traditional medicines

27 January 2022

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

Topics

Awards and Recognition

  • HSA won two awards at the Pro-Enterprise Panel - Singapore Business Federation (PEP-SBF) Awards 2021

Regulatory Updates and Process Enhancements

  • Facilitate Therapeutic Products (TP) registration and post-approval variation

  • Finalised guidance on e-labelling of TP

  • New regulations for Cell, Tissue and Gene Therapy Products (CTGTP)

  • Refined Medical Devices (MD) Product Classification Guide

  • Enhanced Medical Device Information and Communication System (MEDICS) to capture Unique Device Identification (UDI) data

  • Finalised guidelines for 3D-printed MD

  • MD Grouping Tool

International and Bilateral Collaborations

  • Access Consortium

  • Project Orbis

  • Singapore's HSA and Republic of Korea's (ROK) Ministry of Food and Drug Safety (MFDS) established mutual confidence in the Good Manufacturing Inspections of Pharmaceutical Products

  • International Medical Device Regulators Forum (IMDRF) Medical Device Single Audit Programme (MDSAP)

  • HSA registered medical devices are now eligible for expedited registration pathways in more ASEAN markets

News and Engagements

  • Regulatory Fee Revision for Health Products

  • Complementary Health Products (CHP) Industry Training Workshop Series 2021

  • 2021 WHO-UMC-HSA Inter-Regional Pharmacovigilance Training Workshop: Enhancing Preparedness for Pharmacovigilance

  • Webinar: ISO13485 Certification for Medical Device (MD) Licensed Dealers

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

NEX2US_Issue [PDF, 2806 KB]

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