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Gazette New s News, insights and highlights April 2024 Highlights / Press Release Blogs Library Gazette Highlights / Press Release Our past events and highlights View All Highlights Up Established Strong Connections, Tightened the Community... International Hub Showcasing Advanced Medical Technolog... Connecting Healthcare Leaders, Fostering Connections... Blogs Latest regulatory update View All Blogs Up Malaysia: Directive Overview of Natural Product Registr... Australia: Proposed Revision of Manufacturing Principle... Singapore: MOH ACE Implant Subsidy List (ISL) and HTA P... Library Medical device regulatory guidelines View All Library Up Events Our upcoming events are posted in ATTOPOLIS

Gazette New s News, insights and highlights Featured Highlights / Press Release Blogs Library Gazette Blogs Latest regulatory update 1 day ago Malaysia: Directive Overview of Natural Product Registration Based on 'Guideline on Natural Products with Modern Claim' (w.e.f 4 April 2024) The Drug Control Authorities (PBKD) agreed to register natural products based on the Guideline on Natural Products with Modern Claim,... Apr 9 Australia: Proposed Revision of Manufacturing Principles for Medicines, Active Pharmaceutical Ingredients, and Sunscreens (w.e.f 3 June 2024) Australia will be commencing the PIC/S Guide to GMP – 1 February 2022, PE009-16, starting on 3 June 2024, as the manufacturing principles... Apr 8 Singapore: MOH ACE Implant Subsidy List (ISL) and HTA Process Updates The Ministry of Health (MOH) of Singapore implementing the Implant Subsidy List effectively from 1 December 2023. The list consists of... Apr 3 Hong Kong: MDACS Accepts Marketing Approval from Health Sciences Authority (HSA) of Singapore (w.e.f. 2 April 2024) The Health Sciences Authority (HSA) of Singapore was added to the Medical Device Division (MDD) acceptance list for marketing approval... Apr 2 India: PSUR Online Submission for Medical Devices/In-Vitro Devices Marketing Authorization (w.e.f 01 April 2024) The Circular, PSUR-13011(15)/1/2024-eoffice, was circulated by the Central Drugs Standard Control Organization (CDSCO) regarding the... Mar 27 Singapore: UDI Phase 2 Compliance Date Approaching (w.e.f 1 November 2024) The Health Sciences Authority (HSA) is reminding all stakeholders, manufacturers, registrants, importers, and wholesalers for the... Mar 26 Argentina: ANMAT Reviewing Changes to Sales Conditions for Medicinal Specialties (21 March 2024) Ministry of Health mandated the National Administration of Medicines, Foods, and Medical Technology (ANMAT) through Resolution... Mar 20 Hong Kong: CP-05 for Listed Medical Devices Distributors by MDD (1 March 2024) On March 1, 2024, the Medical Device Division (MDD) released the code of practice (CP-05) specifically for the listed medical device... Mar 19 Taiwan: Essential Insights into Medical Mask Registration Requirements (15 March 2023) Following the amendment for the Medical Mask (CNS 14774 (T5017)) and Disposable Dust Respirators (CNS 14755 (Z2125)) under the... Mar 14 UK: New Guidance for Established Medicines Marketing Authorization Application Process Changes (w.e.f 1 March 2024) Effectively from 1 March 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) released new process changes for the... Mar 6 Singapore: Final Phase for Transition of the ISO 13485 Certification Granted by SAC-Accredited Body for Medical Device Dealer License Applications (w.e.f 1 January 2025) Health Sciences Authority issued a reminder about the final transition year for all medical device dealers to obtain confirmation from... Feb 28 Switzerland: Updated Application Documentation for Medicinal Product Establishment License Discontinuation (w.e.f 9 January 2024) Generally, companies that intend to manufacture and/or distribute medicinal, transplant, gene therapy products, or genetically modified... 1 2 3 4 5 Highlights / Press Release Our past events and highlights Established Strong Connections, Tightened the Community... View All Highlights Up Library Medical device regulatory guidelines View All Library Up Events Our upcoming events are posted in ATTOPOLIS View All Events Up

Gazette New s News, insights and highlights April 2024 Highlights / Press Release Blogs Library Gazette Library Medical device regulatory guidelines Highlights / Press Release Our past events and highlights Established Strong Connections, Tightened the Community... View All Highlights Up Blogs Latest regulatory update Malaysia: Directive Overview of Natural Product Registr... View All Blogs Up Events Our upcoming events are posted in ATTOPOLIS View All Events

The Drug Control Authorities (PBKD) agreed to register natural products based on the Guideline on Natural Products with Modern Claim, effective on 4 April 2024, under the provision of Regulation 9, Drug and Cosmetics Control Regulations 1984 (PKDK 1984). Previously, Malaysia only permitted two (2) types of claims for natural products which are Traditional Claims for general health and/or Therapeutic Claims for alleviating mild symptoms. However, there are demands and research that support and call for approval action to claim natural products as other than traditional and therapeutic claims, and these needs were not stated in any registration guidelines for natural products. Hence, NPRA writes out a Guideline on Natural Products with Modern Claims to cater to the demands and needs and align with the strategies of Traditional and Complementary Medicine (T&CM) Blueprint 2018-2027 (Health Care) in reinforcing the T&CM regulations and medicinal materials. IMPLEMENTATION OVERVIEW Natural product registration will be evaluated under Abridged Evaluation The duration of product registration is 116 working days for Single Products and 136 working days for Combined Products. Manufacturers are not obligated to obey the OECD Good Laboratory Practise (GLP) but must comply with the Guidelines on GMP for Traditional Medicines and Health Supplements. Certificate of Analysis (COA) must be submitted with testing documentation as listed in the Guidelines of Natural Products with Modern Claims. 2 batches of COA needed for local and imported products. Labelling statement required: “This is a herbal medicine/preparation”. The product category in the QUEST 3+ System is Herbal (medium). All product registration holders and manufacturers should take on of the newly approved claim under natural product registration. Now, there are three (3) types of natural product claims can be implemented in the product registration. Source: National Pharmaceutical Regulatory Agency (NPRA) Contact us at info@arqon.com for more information.

Australia will be commencing the PIC/S Guide to GMP – 1 February 2022, PE009-16, starting on 3 June 2024, as the manufacturing principles for manufacturing medicines, active pharmaceutical ingredients (API), and sunscreens. However, the principal adoption does not apply to Annexes 4, 5, and 14. Key changes adopted in the latest guide are: Annex 13: Updated information and requirements to address issues related to the manufacture of investigational medicinal products Annex 16: Providing information and requirements of the certification by the authorized person and on the batch release of medicinal products Manufacturers are advised to ensure the requirements stated in the PIC/S Guide to GMP – 1 February 2022, PE009-16 are relevant to your manufacturing operations. GMP Inspectors are expected to apply the new guide during inspections starting from the commencement date. Hence, it is expected all manufacturers able to comply with the guide and adoption. Source: Therapeutic Goods Administration (TGA) Contact us at info@arqon.com for more information.

The Ministry of Health (MOH) of Singapore implementing the Implant Subsidy List effectively from 1 December 2023. The list consists of the implants fully registered with the Health Sciences Authority (HSA) and accessed by the Agency for Care Effectiveness (ACE) to be clinically- and cost-effective for specific clinical indications. Observation highlights a notable growth for the aging demographic, forecasting a surge in implant demand in the years ahead. Consequently, the government has commenced assessment for the first 15 out of 26 implant categories into the Implant Subsidy List. Subsequent categories will undergo phased assessment and integration into the list in the years ahead. As a result, automatic subsidy eligibility for implants will be discontinued. Here are the key takeaways from the briefing session: Horizon Scanning is a separate process from MedTech Evaluation, acting as an early Health Technology Assessment (HTA) process mainly to inform on resource planning. Submission of pipeline medical technologies through the Industry Notification exercise is encouraged to allow for: Provide early technologies visibility to MOH and may be used for early service planning or early adoption to the local public healthcare institutions. Potential horizon scanning assessment as adoption guidance To identify potential HTA topics Companies can submit new implant models via the Accelerated Pathway for expeditious Model Update Process (MUP) processing. MUP fee will be applied by the end of 2024 – Provide the best prices in the first instance for subsidy consideration. Return signed legal documents within stipulated timelines to avoid delays in subsidy listing Source: MOH ACE (Singapore) Contact us at info@arqon.com for more information.