Regulatory Blog

On 23rd October 2025, the South African Health Products Regulatory Authority (SAHPRA) continues to strengthen its regulatory framework to ensure that all medicines—whether registered, imported, or accessed under exceptional circumstances—meet the highest standards of safety, quality, and efficacy. Two of SAHPRA’s most recent guidance documents, namely the Guideline for Section 21 Access to Unregistered Medicines  and the Quality and Bioequivalence Guideline , play a pivotal r

The European Medicines Agency (EMA) has released a draft guideline outlining " Quality standards for mRNA Vaccines " , f ocusing on...

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

The European Medicines Agency (EMA) recently updated the guideline on "Quality and Equivalence of Locally Applied, Locally Acting...

The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and effectiveness of medical devices. In pursuit...

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released a final guidance "Cybersecurity in...

Irelands Health Products Regulatory Authority (HPRA) released final guidance on "Reporting and Investigation of Quality Defects in...

Recently (24 April 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated "General Information...

Recently (10 November 2022), the U.S. Food and Drug Administration published a new Manual of Policies and Procedures (MAPP), MAPP 5015.13...

Recently the National Institute for Food and Drug Surveillance - Invima and the United States Pharmacopeia - USP, celebrated the signing...

Draft PQ/CMC Data Exchange for Electronic Submission of PQ/CMC Data On April 22 2022, USFDA, FDA has released the draft document,...

On 27th August 2021, Irelands Health Products Regulatory Authority (HPRA) released a new "Guide to Reporting and Initial Investigation of...