REGULATORY NEWS & UPDATES

The ARQon Gazette News

      Global Regulatory & Quality Bulletin 
The ARQon Gazette is a compilation of latest updates in the medical device and drug industry. These updates might have an impact to manufacturers and other industry participants.
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August 30, 2019

  • Albania: Amendments proposed to ‘Law on Medical Devices’

  • EU: New MDCG documents on Notified Bodies, the person responsible for regulatory compliance, and implant cards

  • EU: Supplementary guidance released on the Medical Device Vigilance System

  • EU: Gra...

August 30, 2019

  • China : NMPA No. 2019/34 Issuance of Provision n Drug Quality Inspection and and Testing

  • EU/US : EMA/FDA Analysis Shows High Degree of Alignment in Marketing Application Decisions Between EU and US.

  • South Korea :  Five-year Master Plan for Clinical T...

June 28, 2019

  • China - CFDA Announcement No. 2017/187: Announcement on Cancellation of Drug Protection Fees, Certification Fees, Import / Export Licences Fees of Narcotic and Psychotropic Drugs

  • Philippines - FDA Circular No. 2012-007-A: Amending FDA Circular No. 2012-007: Re...

March 29, 2019

  • Australia - Procedure for Priority Review / Accelerated Approval

  • China - NMPA Announcement 2019/10: Adjusting Classification of 12 Types of Drugs

  • South Korea - Procedure for Applying for a Manufacturing / Wholesale Licence

  • Taiwan - MOHW Announcement...

November 5, 2018

  • Australia - Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2018

  • Brazil - Questions and Answers: Resolution RDC 242/2018 on Registration of Specific Medicinal Products

  • Canada - Form: Post-Notice of Compliance Changes: Level III

  • Chin...

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