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Blogs
Latest regulatory update
2 days ago
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...
3 days ago
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....
Jan 13
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...
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