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China: New Wire Assembly Standards (w.e.f. 1 October 2025)
The National Certification and Accreditation Administration (CNCA) recently announced changes to the national standards for wire...

ARQon
Feb 24, 20252 min read


India: CDSCO Introduces New Online Module for Additional Cosmetic Variants
The Central Drugs Standard Control Organization (CDSCO) continues its effort to enhance efficiency and transparency in regulatory...

ARQon
Feb 19, 20252 min read


U.K.: MHRA's New Framework for Digital Mental Health Technologies
The Medicines and Healthcare Products Regulatory Agency (MHRA) released new guidance to help manufacturers navigate the UK medical device...

ARQon
Feb 18, 20252 min read


India: Extended Deadline for Small and Medium Pharma Manufacturers to Comply with Schedule M (w.e.f. 31 December 2025)
The Ministry of Health and Family Welfare has announced a proposed amendment to the Drugs Rule, 1945, extending the compliance timeline...

ARQon
Feb 11, 20252 min read


Singapore: Simplify CTGTP Licensing with SHARE (w.e.f. 10 February 2025)
The Health Sciences Authority (HSA) is excited to announce the launch of SHARE (Singapore Health Product Access and Regulatory E-System)...

ARQon
Feb 10, 20252 min read


Malaysia: Online Advertisement Applications Begin March 2025
The Medical Device Authority (MDA) is set to enhance its application process by transitioning to a fully online system for advertisement...

ARQon
Feb 6, 20251 min read


Australia: Transition from URPTG to PRAC (w.e.f. March 2025)
The Therapeutic Goods Administration (TGA) has announced significant updates to its recall process, slated for implementation in early...

ARQon
Feb 6, 20252 min read


Ireland: The Nordic Packaging Pilot and Joint Packs Initiative
The landscape of medicine packaging in Europe is evolving to address challenges related to medicine availability, particularly for...

ARQon
Jan 28, 20252 min read


Finland: EU F-Gas Regulation for HFC-Containing Inhalers (w.e.f. 1 January 2025)
Effectively from 1 January 2025 , new regulatory requirements have come into effect for placing inhalation sprays containing...

ARQon
Jan 22, 20252 min read


Vietnam: Medical Device Import License Extended to 30 June 2025
The Ministry of Health of Vietnam (MOH) recently issued Decree No. 04/2025/ND-CP, introducing amendments and supplements to Decree No....

ARQon
Jan 21, 20252 min read


Malaysia: NPRA’s New Protocol Assessment and Testing Procedure for Registered Vaccine Products
The National Pharmaceutical Regulatory Agency (NPRA) is set to introduce key initiative aimed at strengthening the quality monitoring of...

ARQon
Jan 13, 20252 min read


China: New Updates for Pharmaceutical Excipients and Packaging Materials Appendices to GMP (w.e.f. 1 January 2026)
The State Drug Administration of China has released an important update aimed at strengthening the quality management of pharmaceutical...

ARQon
Jan 8, 20252 min read


Indonesia: Dried Blood Spot (DBS) Products Now Classified as Medical Devices (w.e.f. 9 December 2024)
Recently, the Ministry of Health of Indonesia announced that Kertas Saring, also known as Dried Blood Spot (DBS) , will be recognized as...

ARQon
Dec 30, 20242 min read


Malaysia: NPRA's Transition to Remote GDP Inspections (w.e.f. 18 December 2024)
The National Pharmaceutical Regulatory Agency (NPRA) has introduced a progressive initiative to improve the regulatory process for...

ARQon
Dec 26, 20242 min read


France: Navigating Clinical Trial Compliance Before the January 2025 Deadline
On 31 January 2022, European Regulation No. 536/2014 (CER) on clinical trials of medicinal products officially came into force, replacing...

ARQon
Dec 24, 20242 min read


Indonesia: Online Certification and Medical Device Licensing Systems to Close Temporarily
The Ministry of Health of Indonesia has temporarily closed the Medical Device Licensing and Online Certification Systems for scheduled...

ARQon
Dec 23, 20242 min read


Australia: TGA Updates Labeling Requirements and Guidelines for Injectable Medicines
The Therapeutic Goods Administration (TGA) has announced updates to the labeling requirements and guidelines for injectable electrolyte...

ARQon
Dec 18, 20242 min read


Philippines: Comprehensive Framework for FDA LTO Application of Covered Health Product Establishments
On 22nd November 2024, the Department of Health of the Republic of the Philippines issued Administrative Order No. 2024-0015 , aiming to...

ARQon
Dec 17, 20242 min read


Singapore: HSA Launches Pilot for Change Management Program (CMP) Targeting SaMD and AI-Driven Innovations (w.e.f 4 December 2024)
Singapore's Health Sciences Authority (HSA) is taking a significant step toward modernizing regulatory frameworks with its pilot for the...

ARQon
Dec 11, 20241 min read


China: NMPA Introduces Interim Provisions on Domestic Responsible Persons Designated by Overseas Drug Marketing Authorization Holders (w.e.f 1 July 2025)
To enforce the Drug Administration Law of the People’s Republic of China and the Vaccine Administration Law of the People’s Republic of...

ARQon
Dec 10, 20242 min read
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