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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


United Kingdom: MHRA Urges MAHs to Finalize Windsor Framework Adjustment
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a final call reminding marketing authorization holders...

ARQon
Dec 3, 20241 min read


Canada: Key Guidelines to Crafting an Effective CAPA Plan by Health Canada
Health Canada releases step-by-step guidance on developing an effective Corrective and Preventive Action Plan (CAPA), consisting of three...

ARQon
Dec 2, 20241 min read


Vietnam: Addressing Import License Expirations in Vietnam (by 25 December 2024)
On behalf of the Ministry of Health of Vietnam, the Infrastructure and Medical Device Administration (IMDA) has requested all related...

ARQon
Dec 2, 20241 min read


Malaysia: NPRA Bans Chloroform and Chloroform Spirit as Preservatives (w.e.f. 19 November 2024)
Effective 19 November 2024 , the National Pharmaceutical Regulatory Agency (NPRA) has issued Directive No. 16/2024, announcing the...

ARQon
Nov 27, 20242 min read


Australia: Key Deadlines for Patient-Matched Medical Devices (PMDDs)
The Therapeutics Goods Administration (TGA) has established a transition period to facilitate smooth transitions and allows continued...

ARQon
Nov 26, 20242 min read


Thailand: Guidelines for Document Referencing, Transfers, & Compliance in Medical Device Applications (w.e.f. 20 September 2024)
In alignment with the guidelines for licensing requests or notifications of medical device details by individuals, entities, or...

ARQon
Nov 20, 20242 min read


Nigeria: Zero VAT on Pharmaceuticals and Medical Devices
On the 9 October 2024, the Nigerian Federal Ministry of Health and Social Welfare has finalized an Executive Order implementing zero...

ARQon
Nov 13, 20241 min read


Indonesia: New Requirements for Medical Device Distributors Licensing Compliance (w.e.f 1 January 2025)
The Ministry of Health of Indonesia has introduced new guidelines for medical device distributors to enhance regulatory compliance,...

ARQon
Nov 12, 20241 min read


Belgium: Reminder End of Transition Period & Important Year-End Deadlines for Submitting Dossiers to the FAMHP
End of Transition Period for Clinical Trials FAHMP reminds all stakeholders, that starting from 31 January 2025 , all clinical trials...

ARQon
Nov 6, 20241 min read


Switzerland: Swissmedic Enhances Fast-Track and Temporary Authorization Processes for Human Medicine (w.e.f 15 Oct 2024)
Swissmedic, the Swiss regulatory authority for therapeutic products, has introduced updates to its guidance documents for the Fast-track...

ARQon
Nov 5, 20242 min read


New Zealand: Rollout New Life Changing Medicines for Public Health (w.e.f 1 October 2024)
In a significant advancement in healthcare, Pharmac, Te Aho o Te Kahu | Cancer Control Agency, Ministry of Health and Health New Zealand...

ARQon
Oct 30, 20241 min read


US: FDA’s DSCSA Exemptions, Waiver, & Exception
FDA’S Exemptions Granted to Trading Partners The U.S. Food and Drug Administration (US FDA) recently announced broad exemptions under the...

ARQon
Oct 29, 20242 min read


Australia: Critical Challenge for Medical Devices Due to 3G Network Shutdown
Starting on 28 October 2024 , both Telstra and Optus will be shutting down their third-generation (3G) networks. This follows the earlier...

ARQon
Oct 22, 20241 min read
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