Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

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 22 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 312 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 273 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 273 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 232 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 232 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 232 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 232 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 232 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 193 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 192 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 193 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 152 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 152 min read

Swissmedic Guidnce: A Closer Look at Marketing Authorisation Transfers, DHPC, and RMP Submissions

As the Swiss life sciences sector grows increasingly global and collaborative, Switzerland’s regulatory authority, Swissmedic , continues...

Sharan Murugan

Jul 92 min read

EMA’s CTIS Framework: Decoding the EMA Clinical Trial Information System-A Practical Guide for Sponsors

In an era of data-driven drug development, the European Medicines Agency (EMA) has launched a transformative regulatory framework : the...

Sharan Murugan

Jul 92 min read

USFDA Guidance: Drug Development for Myelodysplastic Syndromes (MDS)

Myelodysplastic syndromes (MDS) are a group of complex, clonal blood disorders that predominantly affect older adults and may progress to...

Sharan Murugan

Jul 52 min read

USFDA’s Draft Guidance: Aluminum Content and Labeling for Small Volume Parenteral Drug Products in Parenteral Nutrition

Aluminum contamination in parenteral nutrition (PN) has long posed a silent but serious risk—especially to vulnerable populations like...

Sharan Murugan

Jul 23 min read

EMA NDSG Work Plan: Inside the Network Data Steering Group Workplan 2025–2028

In an era where data drives decisions and innovation defines progress, the European Medicines Agency (EMA) and Heads of Medicines...

Sharan Murugan

Jul 23 min read

USFDA Q&A Guidance: Remote Regulatory Assessments (RRA) and Guidance on Antibacterial Therapies (Q&A) and Early Lyme Disease

The U.S. Food and Drug Administration (FDA) has finalized its guidance document on " Conducting Remote Regulatory Assessments (RRAs) ,"...

Sharan Murugan

Jun 292 min read