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Sharan Murugan
Nov 11, 20242 min read
South Africa's SAHPRA: Communication to Industry on Quality Variations
The SAHPRA released a " Communication to Industry on Quality Variations " document that addresses updates on the submission requirements...
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Sharan Murugan
Oct 6, 20242 min read
EMA Guideline: Quality and Equivalence of Locally Applied, Locally Acting Cutaneous Products
The European Medicines Agency (EMA) recently updated the guideline on "Quality and Equivalence of Locally Applied, Locally Acting...
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Sharan Murugan
Feb 4, 20242 min read
USFDA Guidance: "Understanding FDA's QMSR Final Rule: What You Need to Know for the Transition Period"
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and effectiveness of medical devices. In pursuit...
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Sharan Murugan
Oct 2, 20231 min read
USFDA MD Guidance: Cybersecurity-Quality System Considerations & Content of Premarket Submissions
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released a final guidance "Cybersecurity in...
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Sharan Murugan
May 9, 20232 min read
Ireland's HPRA: Guidance on Reporting & Investigation of Quality Defects
Irelands Health Products Regulatory Authority (HPRA) released final guidance on "Reporting and Investigation of Quality Defects in...
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Sharan Murugan
Apr 29, 20231 min read
South Africa: Information Guideline and Quality and Bioequivalence guidelines Aligning with EMA/ICH
Recently (24 April 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated "General Information...
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Sharan Murugan
Nov 12, 20221 min read
USFDA POLICY AND PROCEDURES: Quality Assessment for Products in Expedited Programs
Recently (10 November 2022), the U.S. Food and Drug Administration published a new Manual of Policies and Procedures (MAPP), MAPP 5015.13...
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Sharan Murugan
Aug 9, 20221 min read
Colombia's Invima and USP: Memorandum to Strenghthen the Quality of Medicine
Recently the National Institute for Food and Drug Surveillance - Invima and the United States Pharmacopeia - USP, celebrated the signing...
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Sharan Murugan
Apr 24, 20221 min read
USFDA Guidance on “Pharm. Quality/CMC Data Exchange" and Drug Products containing Nanoparticles
Draft PQ/CMC Data Exchange for Electronic Submission of PQ/CMC Data On April 22 2022, USFDA, FDA has released the draft document,...
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Sharan Murugan
Sep 2, 20212 min read
Guide to Reporting and Initial Investigation of Quality Defects-Ireland HPRA
On 27th August 2021, Irelands Health Products Regulatory Authority (HPRA) released a new "Guide to Reporting and Initial Investigation of...
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