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Sharan Murugan
13 hours ago2 min read
SAHPRA South Africa: Renewal of the Certificate of Registration - Fee Schedule and Explanatory Notes
The South African Health Products Regulatory Authority (SAHPRA)Â has updated its " Fee Schedule and Explanatory Notes " Â to renew human...
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Sharan Murugan
2 days ago2 min read
Navigating UK MHRA Guidance: Registration and Regulation of Medical Devices in the UK
The Medicines and Healthcare Products Regulatory Agency (MHRA) Â oversees the regulation and registration of medical devices within the...
6 views0 comments
Sharan Murugan
Feb 122 min read
South Africa's SAHPRA: Renewal Process for Human -A Comprehensive Guide
The South African Health Products Regulatory Authority (SAHPRA) is responsible for monitoring, evaluating, and regulating the renewal of...
21 views0 comments
Sharan Murugan
Feb 122 min read
EMA Announcement: Regular Scientific Advice Procedure for High-Risk Medical Devices
In collaboration with the European Commission, the European Medicines Agency (EMA) has launched (10 February 2025) a regular...
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Sharan Murugan
Feb 92 min read
UK MHRA Guidance: Software and AI as a Medical Device
The UK Medicines and Healthcare Products Regulatory Agency (MHRA)Â updated its guidance on Software and Artificial Intelligence (AI) as a...
12 views0 comments
Sharan Murugan
Feb 92 min read
UK MHRA Guidance: Managing Clinical Trial Authorisations & Safety Reporting (Updated 2025)
The UK Medicines and Healthcare products Regulatory Agency (MHRA)Â has updated its guidance on " Clinical trials for medicines: manage...
18 views0 comments
Sharan Murugan
Feb 82 min read
UK MHRA Guidance: Exceptions and Modifications to the EU Good Pharmacovigilance Practices (GVP) for UK MAHs
The Medicines and Healthcare Products Regulatory Agency (MHRA) has released updated guidance on pharmacovigilance requirements that...
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Sharan Murugan
Feb 52 min read
UK MHRA Draft Guideline: Individualised mRNA Cancer Immunotherapies
The Medicines and Healthcare products Regulatory Agency (MHRA) has recently initiated a public consultation on draft guidance for "...
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Sharan Murugan
Feb 52 min read
USFDA Guidance: Institutional Review Board (IRB) Written Procedures
Institutional Review Boards (IRBs) play a crucial role in safeguarding the rights and welfare of human research subjects. To enhance...
5 views0 comments
Sharan Murugan
Feb 13 min read
USFDA Guidance: Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis and Reduce the Risk of Transmission of Mycobacterium tuberculosis
The U.S. Food and Drug Administration (USFDA) has released two important guidance documents addressing the risks of sepsis and...
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Sharan Murugan
Feb 13 min read
UK MHRA Guidance: Regulatory Framework for Licensing, Importing, and Supplying Medicines in the UK
The UK Medicines and Healthcare Products Regulatory Agency (MHRA)Â has issued several guidance documents detailing the licensing,...
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Sharan Murugan
Feb 13 min read
IMDRF Med Dev Guidance: Good Machine Learning Practice (GMLP) for Medical Device Development: IMDRF’s Guiding Principles
The International Medical Device Regulators Forum (IMDRF)Â has released its final guidance document (IMDRF/AIML WG/N88:2025)Â outlining...
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Sharan Murugan
Jan 263 min read
South Africs's SAHPRA Guidance: on Medical Device Adverse Event Reporting
The South African Health Products Regulatory Authority (SAHPRA)Â has issued comprehensive guidelines to streamline the reporting of...
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Sharan Murugan
Jan 262 min read
South Africs's SAHPRA Communication: Regulatory Information Management System – Application Withdrawal
The South African Health Products Regulatory Authority (SAHPRA)Â has issued a Communication to the industry on the process for the...
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Sharan Murugan
Jan 262 min read
Malaysia’s NPRA: Drug Registration Guidance Document (DRGD), 3rd Edition, Ninth Revision January 2025
Malaysia’s Drug Registration Guidance Document (DRGD) is a cornerstone for pharmaceutical compliance. The " Drug Registration Guidance...
19 views0 comments
Sharan Murugan
Jan 263 min read
Health Canada: Validation Rules for Regulatory Transactions in eCTD and Non-eCTD Formats
Health Canada has released detailed guidances addressing the validation rules for regulatory transactions submitted in two formats: "...
25 views0 comments
Sharan Murugan
Jan 262 min read
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation
The European Medicines Agency (EMA) provided detailed revised guidance "Procedural Advice for Orphan Medicinal Product Designation " for...
5 views0 comments
Sharan Murugan
Jan 212 min read
UK MHRA Guidance: Strengthening Post-Market Surveillance for Medical Devices
On 15 January, the Medicines and Healthcare products Regulatory Agency (MHRA) released a suite of guidance outlining the new PMS...
14 views0 comments
Sharan Murugan
Jan 212 min read
USFDA Guidance: Bioanalytical Method Validation for Biomarkers
On 21st January 2025, the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research issued final guidance "...
99 views0 comments
Sharan Murugan
Jan 192 min read
Swissmedic Guidance: Orphan Drug Designation (ODS)
Swissmedic has published an updated guidance for" Orphan Drug " aimed at streamlining the regulatory process for medicinal products...
14 views0 comments