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Australia's TGA Guidance Blog: Labelling and Presentation Requirements for Listed Medicines
On 9 April 2025, the Therapeutic Goods Administration (TGA) released updated guidance titled “ Understanding Labelling and Presentation...
Sharan Murugan
2 hours ago3 min read
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SFDA Guidance: Requirements for Formal Meetings Between the Drug Sector and Applicants
Th e Saudi Food and Drug Authority (SFDA)Â has issued an updated version (3.1, dated 7 April 2025) of its guideline: " Requirements for...
Sharan Murugan
2 hours ago2 min read
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ICH Guidance Q1: Stability Testing of Drug Substances and Drug Products (Step 2 Draft 2025)- Public Consultation
The International Council for Harmonisation (ICH) has released a significant update to its stability testing guidelines, consolidating...
Sharan Murugan
5 days ago2 min read
43 views
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EMA Guidance: Anonymisation and Confidentiality in Risk Management Plans (RMPs)
The European Medicines Agency (EMA)Â has published a revised guideline titled " Guidance on the Anonymisation of Protected Personal Data...
Sharan Murugan
5 days ago4 min read
8 views
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EMA Guidance: Procedural Advice on Paediatric Applications
The European Medicines Agency (EMA) has issued updated guidance " Procedural advice on Paediatric Applications " to support stakeholders...
Sharan Murugan
5 days ago3 min read
4 views
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UK MHRA Guidance: Risk Minimisation Measures for Medicines
The Medicines and Healthcare products Regulatory Agency (MHRA)Â has published updated guidance on " Risk Minimisation Measures (RMMs)Â for...
Sharan Murugan
5 days ago2 min read
4 views
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UK MHRA Guidance: How to Notify a Clinical Investigation for a Medical Device & CTR Signed to Law
Before starting any clinical investigation involving a medical device in the UK, it is a legal requirement to notify the Medicines and...
Sharan Murugan
5 days ago3 min read
5 views
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Medical Devices: Post-Market Surveillance – Global NCAR Exchange Simplified
The International Medical Device Regulators Forum (IMDRF) has released the fifth edition of its guidance titled “ Medical Devices:...
Sharan Murugan
Apr 82 min read
16 views
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EMA Draft Guideline: Quality Aspects of mRNA Vaccines
The European Medicines Agency (EMA) has released a draft guideline outlining " Quality standards for mRNA Vaccines " , f ocusing on...
Sharan Murugan
Apr 82 min read
22 views
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SAHPRA Guideline: Section 21 Access to Unregistered Medicines
The South African Health Products Regulatory Authority (SAHPRA)Â has updated its Guideline " Section 21 Access to Unregistered Medicines "...
Sharan Murugan
Apr 63 min read
41 views
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Swissmedic’s Guidance: Packaging, Prior Notification Procedures, Fast-Track Authorisation, Regulatory Meetings & Temporary Authorisations
Swissmedic, the Swiss Agency for Therapeutic Products, has released multiple updated guidance documents in April 2025 that impact...
Sharan Murugan
Apr 62 min read
9 views
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EMA’s Reflection Paper: Linking to ePI from EU Medicine Packages – A Digital Leap in Patient Information
The European Medicines Agency (EMA) published on 31 March 2025 a draft " Reflection paper on linking to electronic Product Information...
Sharan Murugan
Apr 54 min read
19 views
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UK MHRA Guidance: National Assessment Procedure for Medicines, Submission and Assessment timetables for Innovative Medicines Applications
The Medicines and Healthcare Products Regulatory Agency (MHRA)Â has introduced a " National Assessment Procedure for Medicines " Â for...
Sharan Murugan
Apr 32 min read
30 views
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UK MHRA Guidance: Periodic Safety Update Reports (PSURs) for Medicinal Products
Ensuring the ongoing safety and efficacy of medicinal products is a cornerstone of pharmacovigilance. In the United Kingdom, the...
Sharan Murugan
Apr 13 min read
32 views
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UK MHRA: Guidance for Established Medicines -Marketing Authorisation Application Changes
The regulatory landscape for pharmaceuticals is constantly evolving, and the UK Medicines and Healthcare products Regulatory Agency...
Sharan Murugan
Apr 12 min read
21 views
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