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India: Sampling Regulatory Framework for Drugs, Cosmetics, & Medical Devices for Drug Inspectors (9 February 2024)
The Central Drugs Standard Control Organization (CDSCO) released a circular of the regulatory guidelines for the sampling procedure of...

ARQon
Feb 20, 20242 min read


New Zealand: EPA Enforces Ban PFAS Usage in Cosmetic Products (31 December 2026) & Amendments to Cosmetic Products Group Standard (25 January 2024)
On the 30th January 2024, the Environmental Protection Authority (EPA) decided to eliminate Per/Poly- fluoroalkyl substances (PFAS) in...

ARQon
Feb 14, 20242 min read


UK: 2 New Approved Bodies Appointed for MHRA to Certify Medical Devices (31 January 2024)
On 31 January 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the appointment of 2 new Approved Bodies,...

ARQon
Feb 7, 20241 min read


China: CMDE Publishes 12 Registration Review Guidance & Research Review Registration Guidelines for Main Raw Ingredients of IVD Reagents
On the 2nd January 2024, the Device Review Centre of the State Food and Drug Administration released the notice on the revision for 12...

ARQon
Feb 6, 20241 min read


Malaysia: MDA Releases Guidance for Personal Use Medical Device Importation
The Medical Device Authority (MDA) released guidance for the importation of personal use medical devices and the guidance is applied to...

ARQon
Feb 1, 20242 min read


Mexico: DIGIPRiS Enhances Efficiency of Evaluation Time for Clinical Trials & Research
Cofepris implementing a new platform for processing the research and clinical trials digitally, named Digital Platform for Research and...

ARQon
Jan 29, 20241 min read


US: Additional Submission Tools by FDA for Cosmetic Product Facility Registration & Product Listing
On 8 January 2024, the US Food and Drug Administration (FDA) rolled out a new authoring tool for cosmetic product facility registration...

ARQon
Jan 18, 20241 min read


India: National Single Window System (NSWS) as One-Stop Centre for Approvals (15 January 2024)
The National Single Window System Portal (NSWS) was launched on 1 January 2024 as a one-stop centre to facilitate investors and...

ARQon
Jan 16, 20241 min read


Malaysia: Directive on Regulatory Measures for Cosmetic Manufacturers Not Complying with GMP (1 July 2024)
The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia decided to enforce stringent measures against cosmetics manufacturers...

ARQon
Jan 9, 20241 min read


Denmark: MAHs Advised to Revise Summary of Product Characteristics for Medicinal Products (22 January 2024)
WHO Collaborating Centre (WHOCC) updated the ATC/DDD list of 5TH Levels on 12 December 2023 and the Danish Medicines Agency (DMA)...

ARQon
Jan 4, 20241 min read


Bahrain: NHRA Revised Exemption Guideline for Medical Devices Importation (w.e.f 1 January 2024)
Starting 1 January 2024, the National Health Regulatory Authority (NHRA) of Bahrain will implement a new revision of exemption for...

ARQon
Jan 3, 20241 min read


Mexico: New Rules of IVD Medical Devices Updated by ANVISA (1 June 2024)
ANVISA published a new Collegiate Board Resolution, RDC 830/2023 on the 11th of December 2023, updating the rules for in-vitro diagnosis...

ARQon
Jan 2, 20241 min read


Pakistan: In-Depth Guidance by DRAP on Application of Drug Product Specifications
The Drug Regulatory Authority of Pakistan (DRAP) decided to release the guidance of the finished drug product specifications to the...

ARQon
Dec 27, 20232 min read


EMA: GMDP IWG Extends Certificates Validity for Inspections of Pharmaceutical Factories & Wholesalers (end of 2024)
On 7th December 2023, the European Medicines Agency (EMA) updated the regulatory expectations and GMP certificates following the Covid-19...

ARQon
Dec 26, 20231 min read


China: CDE Announces Updates for Electronic Submission of Drug Registration Application (1 March 2024)
The Centre for Drug Evaluation (CDE) reviews its management of electronic submission and electronic common technical dossier (eCTD)...

ARQon
Dec 20, 20232 min read


Indonesia: Temporary Closure of Medical Devices Licensing System, PKRT, and Online Certificates
Due to the scheduled maintenance system, the Ministry of Health (MOH) announced the temporary closure of the medical device licensing...

ARQon
Dec 19, 20232 min read


Hong Kong: MDD Releases GN-10 - Changes Guide for Listed Medical Devices (1 January 2024)
The Medical Device Division (MDD) issued a guidance, “Guidance Notes on Changes for Listed Medical Device (GN-10)” to guide the Local...

ARQon
Dec 13, 20232 min read


Singapore: SHARE Portal for Cell, Tissue, & Gene Therapy Products Notification & Notices (CTGTP)
As part of providing a smooth regulatory process for cell, tissue, and gene therapy products (CTGTP) dealer’s notice and class 1 CTGTP...

ARQon
Dec 12, 20231 min read


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...

ARQon
Dec 6, 20231 min read


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...

ARQon
Dec 5, 20231 min read
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