top of page
Search


Taiwan: TFDA Revolutionizes Cosmetics Industry with New GMP Standards
Starting on 1 July 2024, the Good Manufacturing Practise (GMP) Standards were implemented in the cosmetics industry, specifically for...

ARQon
Aug 1, 20241 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...

ARQon
Jul 30, 20242 min read


Hong Kong: Enhanced Measures Announced by DH for Medical Device Procurement Strategy
On the 4th of July 2024, the Department of Health (DH) announced its movement towards the second phase in enhancing the measures of...

ARQon
Jul 24, 20242 min read


Ireland: Latest Insights about Windsor Framework (Q&A)
After the United Kingdom’s exit from the European Union, the UK and EU established the Windsor Framework, aiming to restore the smooth...

ARQon
Jul 23, 20243 min read


Australia: Navigating New Regulation Changes for Medical Devices
The Therapeutic Goods Administration (TGA) revised the medical device regulations and introduced the amendments on the 26th of June 2024....

ARQon
Jul 17, 20243 min read


China: NMPA Outlines New Standards for Radiofrequency Therapy Devices (w.e.f 1 April 2026)
On the 2nd of July 2024, the Centre for Medical Device Evaluation (CMDE) announced the clarification by the National Medical Products...

ARQon
Jul 16, 20241 min read


Australia: New Vaping Legislation Effective from 1 July 2024
Australia introduces new legislation, The Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024, to regulate the...

ARQon
Jul 10, 20242 min read


Singapore: "NextGen MD Initiative" for Next Generation Medical Device Registrations (w.e.f 1 July 2024)
“NextGen MD Initiative” was introduced by the Health Sciences Authority (HSA) on 13 June 2024 to facilitate the registration of...

ARQon
Jul 9, 20241 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...

ARQon
Jul 3, 20242 min read


Thailand: Thai FDA Streamlines Medical Devices Registration Pathway (w.e.f 6 June 2024)
Effective 6 June 2024, the Thailand Food and Drug Administration (TFDA) has executed the new announcement on the registration...

ARQon
Jul 2, 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...

ARQon
Jun 26, 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...

ARQon
Jun 25, 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...

ARQon
Jun 19, 20241 min read


Malaysia: MDA Revokes Compliance Assessment Process Exemption for COVID-19 Test Kit Registration
The Medical Device Authority (MDA) released an announcement on 31 May 2024 about the revocation of the MDA Circular Letter...

ARQon
Jun 18, 20241 min read


France: ANSM Designates AFNOR as the Newest Notified Body
Medical devices to be marketed in the European market must obtain CE Marking as proof the devices meet the highest safety, health, and...

ARQon
Jun 12, 20241 min read


Malaysia: MDA Implements One License Per Establishment Role Policy (w.e.f 1 July 2024)
Based on the General Directive of the Minister of Health No.1/2024 , announced on 15 April 2024, following the provisions of the Medical...

ARQon
Jun 11, 20242 min read


Thailand: Thai FDA Simplifies Paperwork by Exempting 3 Document Requirements (w.e.f 1 May 2024)
Effectively from 1 May 2024, the Thai FDA decided to exempt 3 hard copy document submissions for all registrants who deal directly with...

ARQon
Jun 5, 20241 min read


India: CDSCO Grants Extension for Import Licenses of Class C and D Medical Devices
The Central Drugs Standard Control Organization (CDSCO) released a circular on 16 May announcing an extension for the importation of the...

ARQon
Jun 4, 20241 min read


Indonesia: Implementation of GDPMD Certification (CDAKB) as Marketing Authorization Requirement
The Indonesia Ministry of Health published an announcement on 11 May 2024, under Announcement No: FR.03.01/E/884/2024 about the...

ARQon
May 29, 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...

ARQon
May 28, 20241 min read
bottom of page
.png)