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EMA Policy 0070 Guidance: Transparency in Clinical Data Publication – Version 1.5 (May 2025)
The European Medicines Agency (EMA)Â has long committed to this principle through Policy 0070, which governs the publication of clinical...

Sharan Murugan
3 days ago3 min read
21 views
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UK MHRA Guidance: International Recognition Procedure – Streamlining Access to Medicines in Great Britain
In a globally interconnected pharmaceutical landscape, regulatory collaboration is essential to ensure timely patient access to safe and...

Sharan Murugan
4 days ago2 min read
7 views
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UK MHRA’s MORE System: Enhancing Post-Market Surveillance of Medical Devices
In a regulatory landscape that continually evolves to ensure public health and safety, the UK Medicines and Healthcare products...

Sharan Murugan
4 days ago3 min read
9 views
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USFDA Announcement: Shortening the Drug Approval Process- Integration of Generative AI by June end & Completion of First AI-Assisted Scientific Review
The U.S. Food and Drug Administration (FDA) has marked a significant milestone in its digital transformation journey by announcing the...

Sharan Murugan
May 132 min read
33 views
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CIOMS Working Group Draft Report: Artificial Intelligence in Pharmacovigilance: Key Takeaways
The field of pharmacovigilance (PV) —the science of detecting, assessing, understanding, and preventing adverse effects or any other...

Sharan Murugan
May 133 min read
34 views
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EMA Network Data Steering Group workplan 2025-2028: Leveraging Data and AI for Enhanced Medicine Regulation
In the evolving landscape of medicines regulation, data and artificial intelligence (AI) have become pivotal tools to enhance public and...

Sharan Murugan
May 113 min read
23 views
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EMA Concept Paper: Advancements in Good Manufacturing Practice for Advanced Therapy Medicinal Products
The pharmaceutical industry continually evolves to adapt to new scientific discoveries and technological advancements. Good Manufacturing...

Sharan Murugan
May 113 min read
17 views
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UK MHRA Guidance: The Northern Ireland MHRA Authorised Route (NIMAR)
The Medicines and Healthcare products Regulatory Agency (MHRA)Â has published updated guidance on " The Northern Ireland MHRA Authorised...

Sharan Murugan
May 112 min read
31 views
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Swissmedic Guidelines: Formal Requirements & GMP Compliance for Foreign Manufacturers
When navigating Switzerland's regulatory landscape for medicinal products, two key guidance documents from Swissmedic stand out for their...

Sharan Murugan
May 33 min read
28 views
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Swissmedic Guidance: Understanding Parallel Imports and the Authorisation of Asian Medicinal Products
Switzerland’s regulatory landscape for pharmaceuticals continues to evolve, balancing patient safety with market efficiency. Two pivotal...

Sharan Murugan
May 32 min read
18 views
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Ireland HPRA’s Guide: Good Distribution Practice (GDP) of Medicinal Products
The Health Products Regulatory Authority (HPRA) of Ireland released Version 8 of its Guide to Good Distribution Practice (GDP) in March...

Sharan Murugan
May 33 min read
18 views
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Announcing Veeva AI: A Bold Leap Toward Intelligent Automation in Life Sciences
The world of pharma and life sciences is abuzz with a major announcement: Veeva Systems has just unveiled Veeva AI , a groundbreaking...

Sharan Murugan
Apr 293 min read
117 views
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USFDA Public Consultation: HL7 FHIR for Study Data from Real-World Data
The U.S. Food and Drug Administration (FDA)Â has announced a major initiative by opening a public docket seeking comments on the "...

Sharan Murugan
Apr 273 min read
21 views
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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
Apr 233 min read
38 views
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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
Apr 232 min read
16 views
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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
Apr 182 min read
113 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
Apr 184 min read
19 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
Apr 183 min read
12 views
0 comments


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
Apr 182 min read
10 views
0 comments


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
Apr 183 min read
5 views
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