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ARQon
Jan 82 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...
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ARQon
Dec 10, 20242 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...
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ARQon
Nov 27, 20242 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...
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ARQon
Nov 13, 20241 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...
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ARQon
Oct 30, 20241 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...
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ARQon
Oct 29, 20242 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...
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ARQon
Sep 11, 20243 min read
Philippines: DOH Guidelines for the Registration of Pharmaceutical Products and Active Pharmaceutical Ingredients Exclusively for Export
On 19 August 2024, the Department of Health of the Philippines issued Administrative Order No.2024-0012, outlining the regulations for...
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ARQon
Aug 14, 20241 min read
PIC/S: Revised PIC/S GMP Guide on Manufacture of Sterile Products (Lyophilization - w.e.f 25 August 2024)
Annex 1 of the PIC/S Good Manufacturing Practise (GMP) Guide on the manufacture of sterile products has been revised and published. The...
19 views0 comments
ARQon
Jul 30, 20242 min read
India: Requirement of Toxicity Studies for New Drugs, SNDs, and FDCs
On the 29th of July 2024, the Central Drugs Standard Control Organization (CDSCO) released new circular on the requirement for toxicity...
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ARQon
Jul 3, 20242 min read
Hong Kong: New Screening Protocol Introduced for Registration Application of Pharmaceutical Products/Substances (w.e.f 1 July 2024)
The Pharmacy and Poisons Board of Hong Kong (“the Board”) announced that the Refuse-to-File (“RTF”) Mechanism will be enforced in the...
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ARQon
Jun 26, 20241 min read
Hong Kong: Medical Gases Endorsed as Pharmaceutical Products (w.e.f 14 June 2026)
Overall responses from full and thorough jurisdictions based on the current situation in Hong Kong and public consultation led by the...
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ARQon
Jun 25, 20241 min read
India: New Self-Declaration Requirement Implemented for Pharmaceuticals & Medical Device Associations (d.d 30 June 2024)
On the 28th and 30th of May 2024, the Department of Pharmaceuticals of India released 2 Standing Orders regarding the new...
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ARQon
Jun 19, 20241 min read
Australia: TGA Adopts PIC/S Guide to GMP Version 16: Manufacturing Principles for Medicines, APIs & Sunscreens (w.e.f 3 September 2024)
On 3 June 2024, the Therapeutic Goods Administration (TGA) amended its Therapeutic Goods (Manufacturing Principles) Determination...
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ARQon
May 28, 20241 min read
China: Optimization of Registration Application for Transferring Overseas-Produced Drugs into Domestic Production
As part of the initiative to boost foreign investments in the pharmaceutical industry and improve high-quality drug developments and...
11 views0 comments
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