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SAHPRA South Africa: Guideline for Classification of Medical Devices and In Vitro Diagnostics (IVDs)
The South African Health Products Regulatory Authority (SAHPRA)Â has released an updated " Guideline for the Classification of Medical...
Sharan Murugan
Mar 12 min read
37 views
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EMA Procedural Advice: Appointment of CHMP, CAT, and PRAC Rapporteurs and Co-Rapporteurs
The European Medicines Agency (EMA)Â has released an updated procedural guidance document on the " Appointment of CHMP, CAT, and PRAC...
Sharan Murugan
Mar 12 min read
24 views
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MHRA Guidance: Format and Content of Applications for Agreement or Modification of a Paediatric Investigation Plan
The Medicines and Healthcare products Regulatory Agency (MHRA)Â has established comprehensive guidelines detailing the " Format and...
Sharan Murugan
Feb 282 min read
22 views
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EMA Addendum: Clinical Development of Vaccines in Immunocompromised Individuals
The European Medicines Agency (EMA) has released an addendum to its Guideline on the " Clinical Development of Vaccines to address the...
Sharan Murugan
Feb 272 min read
11 views
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EMA Concept Paper: Guideline on Mechanistic Models in Model-Informed Drug Development (MIDD)
The European Medicines Agency (EMA) has released a concept paper  proposing the development of a guideline for the assessment and...
Sharan Murugan
Feb 222 min read
24 views
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FDA Philippines: Draft Guidelines for Registration of Chemical and Biological Pharmaceutical Products
The Food and Drug Administration (FDA) of the Philippines has recently published draft guidelines to streamline the registration process...
Sharan Murugan
Feb 222 min read
18 views
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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...
Sharan Murugan
Feb 192 min read
13 views
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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...
Sharan Murugan
Feb 182 min read
29 views
0 comments
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...
Sharan Murugan
Feb 122 min read
36 views
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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...
Sharan Murugan
Feb 122 min read
13 views
0 comments
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...
Sharan Murugan
Feb 92 min read
22 views
0 comments
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...
Sharan Murugan
Feb 92 min read
62 views
0 comments
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...
Sharan Murugan
Feb 82 min read
60 views
0 comments
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 "...
Sharan Murugan
Feb 52 min read
12 views
0 comments
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...
Sharan Murugan
Feb 52 min read
7 views
0 comments