regulatory | Komplyaus.com

Oct 27, 2022

Impending Deadline – TGA Pharmacovigilance Risk Assessment Survey

On 17 October 2022, the TGA indicated its Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is open for completion. In...

Aug 11, 2022

Think Ahead, Be Prepared – TGA Post-market Review

Recently, the Therapeutic Goods Administration (TGA) cancelled the registration of four COVID-19 rapid antigen tests...

Jun 23, 2022

Digital Revolt: Big Data and Veterinary Medicine in the EU

On 13 June 2022, the European Medicines Agency (EMA), unveiled its ‘European Veterinary Big Data Strategy 2022 – 2027’...

May 31, 2022

FDA Update: Risk Management and Preventing Drug Shortages

On 20 May 2022, the FDA issued a draft guidance concerning the role of risk management in the prevention of potential drug shortages...

May 6, 2022

Huh? Benzene in Sunscreen?

On 28 April 2022, the Therapeutic Goods Administration (TGA) recalled certain batches of six sunscreen products due to benzene contamination

Apr 11, 2022

VMD and MPI Simultaneous Review – A vision of Cross-border Regulatory Harmony?

On 16 February 2022, The VMD and MPI published a guiding document concerning the simultaneous review of veterinary medicines...

Mar 23, 2022

New TGA Consultation: Repurposing Medicines

The Therapeutic Goods Association (TGA) is conducting a public consultation concerning the repurposing of medicines listed...

Feb 11, 2022

FDA Policy Update: COVID-19-related Sanitation Tunnels

The FDA has expressed concern surrounding the safety and efficacy of sanitation tunnels developed to combat the spread of COVID-19.

Dec 17, 2021

Australian Business Fined for Alleged Unlawful Advertising of Vaping Products

The Therapeutic Goods Association (TGA) has issued multiple infringement notices to an Australian business amounting to...

Dec 15, 2021

Tomorrow, Today! 3D-Printed Medical Devices at the Point of Care

Historically, the manufacture of 3D-printed medical devices at the point of care (PoC) seemed like science-fiction.

Dec 10, 2021

New TGA Application Form. Medical Device Sponsors, Be Aware!

The Therapeutic Goods Administration (TGA) has indicated a new online form is to be lodged when applying for consent to import...

Dec 6, 2021

Real-World Data and Evidence: The Future in Demonstrating Efficacy?

Regulatory bodies are increasingly considering the expanded usefulness of Real-World Data (RWD) and Real-World Evidence (RWE).

Nov 29, 2021

Last ACVM Pre-Screen Deadline Approaching

The last Agricultural Compounds and Veterinary Medicines (ACVM) pre-screening application deadline for this year is Friday 03 December 2021.

Nov 24, 2021

TGA Medical Device Reforms

The Therapeutic Goods Association (TGA) will reclassify certain medical devices...

Top of page