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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 3, 20253 min read
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 3, 20252 min read
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 3, 20253 min read
USFDA Public Consultation: HL7 FHIR for Study Data from Real-World Data
The U.S. Food and Drug Administration (FDA) has announced a major initiative by opening a public docket seeking comments on the "...
Sharan Murugan
Apr 27, 20253 min read
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 23, 20253 min read
SFDA Guidance: Requirements for Formal Meetings Between the Drug Sector and Applicants
Th e Saudi Food and Drug Authority (SFDA) has issued an updated version (3.1, dated 7 April 2025) of its guideline: " Requirements for...
Sharan Murugan
Apr 23, 20252 min read
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 18, 20252 min read
EMA Guidance: Anonymisation and Confidentiality in Risk Management Plans (RMPs)
The European Medicines Agency (EMA) has published a revised guideline titled " Guidance on the Anonymisation of Protected Personal Data...
Sharan Murugan
Apr 18, 20254 min read
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 18, 20253 min read
UK MHRA Guidance: Risk Minimisation Measures for Medicines
The Medicines and Healthcare products Regulatory Agency (MHRA) has published updated guidance on " Risk Minimisation Measures (RMMs) for...
Sharan Murugan
Apr 18, 20252 min read
SAHPRA Guideline: Section 21 Access to Unregistered Medicines
The South African Health Products Regulatory Authority (SAHPRA) has updated its Guideline " Section 21 Access to Unregistered Medicines "...
Sharan Murugan
Apr 6, 20253 min read
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 6, 20252 min read
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 5, 20254 min read
UK MHRA Guidance: National Assessment Procedure for Medicines, Submission and Assessment timetables for Innovative Medicines Applications
The Medicines and Healthcare Products Regulatory Agency (MHRA) has introduced a " National Assessment Procedure for Medicines " for...
Sharan Murugan
Apr 3, 20252 min read
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 1, 20253 min read
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 1, 20252 min read
EMA's New AI Work Plan: Shaping the Future of Medicines Regulation
The European Medicines Agency (EMA) has unveiled a comprehensive Artificial Intelligence (AI) Work Plan to guide the integration of AI...
Sharan Murugan
Mar 31, 20252 min read
USFDA Guidance: Study Data Technical Conformance Guide – Technical Specifications Document and Data Standards Catalog
The U.S. Food and Drug Administration (FDA) has released the latest version (v6.0) of the Study Data Technical Conformance Guide in...
Sharan Murugan
Mar 30, 20253 min read
UK MHRA Guidance: Blue Guide -Advertising and Promoting Medicines – A Regulatory Overview
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has updated the Appendix 4 Best Practice Guidance of the " Blue Guide:...
Sharan Murugan
Mar 30, 20252 min read
MHRA Guidance: Registering to Manufacture, Import, or Distribute Active Substances
The Medicines and Healthcare products Regulatory Agency (MHRA) has established guidelines " Medicines: Register to manufacture, import...
Sharan Murugan
Mar 26, 20252 min read