Regulatory Blog

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has issued a Request for...

In November 2024, the Medical Device Coordination Group (MDCG)  released " MDCG 2024-14 - Guidance on the implementation of the Master...

The European Medicines Agency (EMA)  has released a comprehensive document " Scientific guidelines with summary-of-product-characteristi...

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued " Call to comply with Windsor Framework arrangements for...

The USFDA  continues to innovate its regulatory landscape with the release of three important guidance earlier today (27 November, 2024)...

The USFDA Center for Devices and Radiological Health  has recently issued three key final guidance documents focusing on orthopedic...

The Medical Device Authority (MDA) in Malaysia has released a comprehensive guidance " Control of Obsolete and Discontinued Medical...

Earlier today (20 November, 2024) the Therapeutic Goods Administration (TGA) released Version 4.0 of its Listed Medicines " Evidence...

The 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review are pivotal initiatives by the USFDA to...

Swissmedic, the Swiss Agency for Therapeutic Products, has introduced its updated  guidance  on " Product Information for Human Medicinal...

This USFDA draft guidance" Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutic s" , issued on 15 November 2024, offers...

The UK MHRA updated its Guidance on " How Marketing Authorisation Applications referred under Article 29 are Handled " and outlines the...

The SAHPRA released a " Communication to Industry on Quality Variations " document that addresses updates on the submission requirements...

As part of the South African Health Product Regulatory Authority’s (SAHPRA) Digitalisation Project, we launched the SAHPRA Engagement...

The Swissmedic guidance released an information sheet titled " Combined Studies: Clinical Investigations of Medical Devices, Medicinal...