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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...

ARQon
Nov 29, 20232 min read


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...

ARQon
Nov 22, 20231 min read


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...

ARQon
Nov 21, 20232 min read


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...

ARQon
Nov 15, 20231 min read


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...

ARQon
Nov 14, 20231 min read


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...

ARQon
Nov 7, 20232 min read


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...

ARQon
Nov 1, 20232 min read


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...

ARQon
Oct 31, 20232 min read


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...

ARQon
Oct 18, 20232 min read


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,...

ARQon
Oct 17, 20232 min read


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...

ARQon
Oct 11, 20231 min read


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...

ARQon
Oct 10, 20231 min read


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...

ARQon
Oct 4, 20231 min read


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...

ARQon
Oct 3, 20231 min read


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...

ARQon
Sep 27, 20232 min read


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...

ARQon
Sep 26, 20231 min read


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...

ARQon
Sep 20, 20231 min read


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...

ARQon
Sep 19, 20232 min read


USA: FDA Drafts Guidelines for Facilities Registration and Listing of Cosmetic Products
As mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the FDA was designated new authorities for Cosmetics which...

ARQon
Sep 13, 20232 min read


Switzerland: Implementation of the MRA for the GMP of Medicinal Products (27 July 2023)
United States (FDA) and Switzerland (Swissmedic) were mutually recognized as regulatory authorities for each country, effectively...

ARQon
Sep 12, 20231 min read
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