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Blogs
Latest regulatory update
![Finland: EU F-Gas Regulation for HFC-Containing Inhalers (w.e.f. 1 January 2025)](https://static.wixstatic.com/media/9446d9_c87b50a598824df29a30d24b1c2cd192~mv2.png/v1/fill/w_303,h_228,fp_0.50_0.50,q_95,enc_auto/9446d9_c87b50a598824df29a30d24b1c2cd192~mv2.webp)
15 hours 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...
![Vietnam: Medical Device Import License Extended to 30 June 2025](https://static.wixstatic.com/media/9446d9_8b63fc5b8c474d819c8416a6bbcbbd98~mv2.png/v1/fill/w_304,h_228,fp_0.50_0.50,q_95,enc_auto/9446d9_8b63fc5b8c474d819c8416a6bbcbbd98~mv2.webp)
2 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....
![Malaysia: NPRA’s New Protocol Assessment and Testing Procedure for Registered Vaccine Products](https://static.wixstatic.com/media/9446d9_736ab677ba374a7e85d439e50e73e0e1~mv2.png/v1/fill/w_303,h_228,fp_0.50_0.50,q_95,enc_auto/9446d9_736ab677ba374a7e85d439e50e73e0e1~mv2.webp)
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...
![China: New Updates for Pharmaceutical Excipients and Packaging Materials Appendices to GMP (w.e.f. 1 January 2026)](https://static.wixstatic.com/media/9446d9_41e77f450108476ab97afe32c86a25f9~mv2.png/v1/fill/w_303,h_228,fp_0.50_0.50,q_95,enc_auto/9446d9_41e77f450108476ab97afe32c86a25f9~mv2.webp)
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...
![Indonesia: Dried Blood Spot (DBS) Products Now Classified as Medical Devices (w.e.f. 9 December 2024)](https://static.wixstatic.com/media/9446d9_91ee453ad30c4800814714aaf45e2d57~mv2.png/v1/fill/w_304,h_228,fp_0.50_0.50,q_95,enc_auto/9446d9_91ee453ad30c4800814714aaf45e2d57~mv2.webp)
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...
![Malaysia: NPRA's Transition to Remote GDP Inspections (w.e.f. 18 December 2024)](https://static.wixstatic.com/media/9446d9_0ef5925b713a4779b980918455e02b00~mv2.png/v1/fill/w_303,h_228,fp_0.50_0.50,q_95,enc_auto/9446d9_0ef5925b713a4779b980918455e02b00~mv2.webp)
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...
![France: Navigating Clinical Trial Compliance Before the January 2025 Deadline](https://static.wixstatic.com/media/9446d9_666743ea402b45c783a25f3d8fea0fe3~mv2.png/v1/fill/w_303,h_228,fp_0.50_0.50,q_95,enc_auto/9446d9_666743ea402b45c783a25f3d8fea0fe3~mv2.webp)
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...
![Indonesia: Online Certification and Medical Device Licensing Systems to Close Temporarily](https://static.wixstatic.com/media/9446d9_f954e50c56ed45a8a4f426160460bdb1~mv2.png/v1/fill/w_304,h_228,fp_0.50_0.50,q_95,enc_auto/9446d9_f954e50c56ed45a8a4f426160460bdb1~mv2.webp)
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...
![Australia: TGA Updates Labeling Requirements and Guidelines for Injectable Medicines](https://static.wixstatic.com/media/9446d9_68c1eab4211c4ada8f77f58b4c0adfa0~mv2.png/v1/fill/w_303,h_228,fp_0.50_0.50,q_95,enc_auto/9446d9_68c1eab4211c4ada8f77f58b4c0adfa0~mv2.webp)
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...
![Philippines: Comprehensive Framework for FDA LTO Application of Covered Health Product Establishments](https://static.wixstatic.com/media/9446d9_537973833aa443c4868819c5cc75af55~mv2.png/v1/fill/w_303,h_228,fp_0.50_0.50,q_95,enc_auto/9446d9_537973833aa443c4868819c5cc75af55~mv2.webp)
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...
![Singapore: HSA Launches Pilot for Change Management Program (CMP) Targeting SaMD and AI-Driven Innovations (w.e.f 4 December 2024)](https://static.wixstatic.com/media/9446d9_00f0513dbb4d4e43afc0a6ecaac254a9~mv2.png/v1/fill/w_304,h_228,fp_0.50_0.50,q_95,enc_auto/9446d9_00f0513dbb4d4e43afc0a6ecaac254a9~mv2.webp)
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...
![China: NMPA Introduces Interim Provisions on Domestic Responsible Persons Designated by Overseas Drug Marketing Authorization Holders (w.e.f 1 July 2025)](https://static.wixstatic.com/media/9446d9_da4b717656d44f81ae8e66f10e6a3867~mv2.png/v1/fill/w_303,h_228,fp_0.50_0.50,q_95,enc_auto/9446d9_da4b717656d44f81ae8e66f10e6a3867~mv2.webp)
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...
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