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USFDA FDA User Fee Rates for FY 2026: A Comparative Overview for Prescription Drugs, Medical Devices, Generics, and Outsourcing Facilities
The U.S. Food and Drug Administration (FDA) has announced On 30 July 2025 , the official user fee rates across its major healthcare...
Sharan Murugan
Aug 2, 20252 min read
USFDA Announcement: Biosimilar User Fee Rates for Fiscal Year 2026 (October 1, 2025 – September 30, 2026)
On 30 July 2025, the U.S. Food and Drug Administration (FDA) officially published the Biosimilar User Fee Rates for Fiscal Year (FY) 2026...
Sharan Murugan
Aug 2, 20252 min read
USFDA Med Dev Guidance: Medical Device User Fee Small Business Qualification and Determination
In July 2025, the USFDA published a revised guidance titled " Medical Device User Fee Small Business Qualification and Determination "...
Sharan Murugan
Jul 31, 20252 min read
EMA Guidance: Procedural Advice on Paediatric Applications
On 25 July 2025 , the European Medicines Agency (EMA) published the latest guidance " Procedural Advice on Paediatric Applications " ....
Sharan Murugan
Jul 31, 20252 min read
ICH -E21 (USFDA) Guidance: Including Pregnant and Breastfeeding Women in Clinical Trials
In May 2025, the FDA, as part of the International Council for Harmonisation (ICH), endorsed and released for consultation the draft E21...
Sharan Murugan
Jul 27, 20253 min read
EMA Guidance: Good Pharmacovigilance Practices (GVP) — Introductory cover note with new Addendum II and GVP Module VI Addendum II – Masking of Personal Data
The European Medicines Agency (EMA) continuously updates its Good Pharmacovigilance Practices (GVP) guidelines to enhance patient privacy...
Sharan Murugan
Jul 27, 20253 min read
UK MHRA Guidance: Regulation of Medical Devices in Northern Ireland: Step-by-Step Guide (2025)
On 24 July 2025 , the UK Government published the latest update to its official guidance: " Regulation of medical devices in Northern...
Sharan Murugan
Jul 27, 20252 min read
Malaysia’s NPRA Guidance: Drug Registration Guidance, What’s Inside?
On 22nd July 2025, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) released the Third Edition, Tenth Revision of the " Drug...
Sharan Murugan
Jul 23, 20252 min read
USFDA's: FDA’s Commissioner’s National Priority Voucher (CNPV) Pilot Program to Accelerate Life-Changing Medicines
The U.S. Food and Drug Administration (FDA) has launched the " Commissioner’s National Priority Voucher (CNPV) Pilot Program " a...
Sharan Murugan
Jul 23, 20252 min read
EMA Guidance: Requirements for Demonstrating Therapeutic equivalence between Orally Inhaled Products (OIP) and Chronic Obstructive Pulmonary Disease (COPD)
On 14 July 2025 , the European Medicines Agency (EMA) published the final revised guideline titled " Guideline on the requirements for...
Sharan Murugan
Jul 23, 20252 min read
India CDSCO Guidance: Subject Expert Committee (SEC), What Pharma and Clinical Trial Teams Need to Know
The Central Drugs Standard Control Organization (CDSCO) under India’s Ministry of Health & Family Welfare has released a detailed...
Sharan Murugan
Jul 23, 20252 min read
India CDSCO Guidance: How to Get Export NOC for Approved & Unapproved New Drugs
The Central Drugs Standard Control Organisation (CDSCO) has published a fresh guidance document titled “ Guidance Document for Issuance...
Sharan Murugan
Jul 23, 20252 min read
European Commission: Guidelines on the Scope of the Obligations for General-Purpose AI Models established by AI Act
On 18 July 2025, the European Commission published detailed Guidelines on the scope of the obligations for providers of general-purpose...
Sharan Murugan
Jul 19, 20253 min read
EMA’s AI Journey: The Rise of Artificial Intelligence in Medicines Regulation
In a world where artificial intelligence (AI) is moving rapidly from theory to practice, regulators are tasked with keeping pace—not only...
Sharan Murugan
Jul 19, 20253 min read
USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products
In July 2025, the U.S. Food and Drug Administration (FDA) published its updated guidance for industry titled “ Formal Meetings Between...
Sharan Murugan
Jul 19, 20253 min read
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation
The European Medicines Agency (EMA) provides structured guidance for sponsors aiming to secure orphan medicinal product designation...
Sharan Murugan
Jul 19, 20252 min read
UK MHRA Guidance: Use of Real-World Data in Clinical Studies to Support Regulatory Decisions (July 2025 Update)
In July 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released updated and expanded guidance on the use of...
Sharan Murugan
Jul 19, 20253 min read
Swissmedic Export Certificates: A Practical Guide for Medical Device Manufacturers
The efficient international supply of medical devices depends not only on innovation but on robust regulatory processes that certify...
Sharan Murugan
Jul 15, 20253 min read
EMA IRIS Guide: How to Create, Submit and Manage IRIS applications, for Industry and Individual applicants
In the ever-evolving regulatory landscape of EU pharmaceuticals, digital solutions are a linchpin for timely and transparent scientific...
Sharan Murugan
Jul 15, 20252 min read
MHRA’s Guidance: Access, New Active Substance and Biosimilar Work-Sharing Initiatives
In an era of rapid pharmaceutical innovation, global collaboration is key to expediting patient access to new therapies. To help patients...
Sharan Murugan
Jul 15, 20252 min read