Australia: TGA Rolls Out New Vaping Regulations (1 January 2024)
Australia will be under a new reformation for vaping and is expecting amendments to the Therapeutic Goods Act 1989 to be introduced...
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ARQon
- 1 day ago
- 1 min
EU: New Approach Application Date for Contact Lenses' UDIs Scheduled on 9 November 2025
According to Regulation (EU) 2017/745, manufacturers are required to assign a Unique Device Identification (UDI) before placing their...
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ARQon
- Nov 29
- 2 min
Vietnam: MOH Proposes Revision for Drug & Medicinal Ingredients Registration & Circulation
The Ministry of Health of Vietnam (MOH) has taken a step forward in simplifying the registration and circulation of drugs and medicinal...
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ARQon
- Nov 22
- 1 min
UK: MHRA Introduces Eligibility Checker for MAAs via IRP (20 November 2023)
As we are approaching 1 January 2024 in 6 weeks’ time, that means the EC Decision Reliance Procedure (ECDRP) will be replaced by the...
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ARQon
- Nov 21
- 2 min
Malaysia: Implementation of the Updated Guideline FRP by NPRA (1 January 2024)
On the 390th meeting on the 3rd of November 2023, the National Pharmaceutical Regulatory Authority (NPRA) agreed to update the Guideline...
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ARQon
- Nov 15
- 1 min
Australia: BICON Revises Import Requirements for Retail Cosmetics and Soaps (18 October 2023)
Commencing 18 October 2023, BICON – Department of Agriculture, Fisheries, and Forestry of Australia decided to implement the new...
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ARQon
- Nov 14
- 1 min
USA: FDA Delays Enforcement of Facilities Registration & Listing of Cosmetic Products (1 July 2024)
In the previous blog (USA: FDA Drafts Guidelines for Facilities Registration and Listing of Cosmetic Products), we discussed the new FDA...
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ARQon
- Nov 7
- 2 min
Hong Kong: New Drug Approval Mechanism "+1" (1 November 2023)
Commencing efficiently from 1 November 2023, the Pharmacy and Poisons Board will be implementing the new “1+ mechanism” to facilitate the...
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ARQon
- Nov 1
- 2 min
Bahrain: Revision of Fast-Track Registration Procedures for Pharmaceutical Products (Resolution 32)
The National Health Regulatory Authority (NHRA) released Circular No. (26) 2023, on the revision of Resolution 32 regarding the...
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ARQon
- Oct 31
- 2 min
Malaysia: MDA Ends CFS Issuance for Export-Only Medical Devices (1 October 2023)
Effectively from 1 October 2023, the Medical Device Authority (MDA) ceased the issuance of Certificate of Free Sale (CFS) for export-only...
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ARQon
- Oct 18
- 2 min
Switzerland: Revision of MedDO & IvDO for Non-Medical Purpose Products (1 November 2023)
The Federal Council of Switzerland decided to regulate the changes in the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro...
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ARQon
- Oct 17
- 2 min
Regulation of Pharmaceuticals, Firm Types, Requirements, Methods, & Schedules - Western Pharma GDP
Taiwan Food and Drug Administration (TFDA) updated the pharmaceuticals enforcement including the pharmaceutical firm types, requirements,...
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ARQon
- Oct 11
- 1 min
Mexico: COFEPRIS Modifies NOM 177 for Registration of Generic and Biosimilars Medicines
COFEPRIS decided to modify the Official Mexican Standard (NOM) 177 in order to facilitate the registration of generic and biosimilar...
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ARQon
- Oct 10
- 1 min
Singapore: Enforcement of GMP-Compliance Evidence for Drug Substance (DS) Manufacturers
On 29 September 2023, the Health Science Authority (HSA) of Singapore published the decision from the initial communication with...
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ARQon
- Oct 4
- 1 min
Brazil: New Subject Code for Microbiological Product (Simplified Registration Route)
Previously on 10 April 2023, Anvisa regulated a simplified registration route for microbiological products under Joint Ordinance...
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ARQon
- Oct 3
- 1 min
Ireland: Free Sale Applications Certificates for Devices in Compliance with Regulation 2023/607
Health Products Regulatory Authority (HPRA) released a new application form for the free sale certificates for medical devices qualifying...
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ARQon
- Sep 27
- 2 min
China: Implementation of Toothpaste Regulatory Regulations and Simplification Filing Requirements
The National Medical Products Administration (NMPA) announced the implementation of the requirements of toothpaste regulatory regulations...
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ARQon
- Sep 26
- 1 min
Qatar: MOPH Obligates Document Authenticity Verification for IMD Registration (1 October 2023)
Ministry of Public Health (MOPH) released Circular NO (DHP/2023/100) on 12 September 2023 extending the commission by Ministerial...
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ARQon
- Sep 20
- 1 min
Australia: Full Enforcement of the Medicinal Dosage Form for Sports Supplements
As regulated in Subsection 7 (1) of the Therapeutic Goods Act 1989 (the Act) released on 23 September 2020, all sports supplements that...
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ARQon
- Sep 19
- 2 min
Indonesia: BPOM Published Regulation No.17 on Guidelines for Cosmetic Products Information Documents
In accordance with Regulation No. 17/2023, Guidelines for Cosmetic Product Information Documents, the Indonesia National Agency of Food...
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