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Blogs
Latest regulatory update
2 days ago
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...
Jan 8
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...
Dec 30, 2024
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...
Dec 26, 2024
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...
Dec 24, 2024
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...
Dec 23, 2024
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...
Dec 18, 2024
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...
Dec 17, 2024
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...
Dec 11, 2024
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...
Dec 10, 2024
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...
Dec 3, 2024
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...
Dec 2, 2024
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...
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