Regulatory Blog

The U.S. Food and Drug Administration (FDA) has announced On 30 July 2025 , the official user fee rates across its major healthcare...

On 30 July 2025, the U.S. Food and Drug Administration (FDA) officially published the Biosimilar User Fee Rates for Fiscal Year (FY) 2026...

In July 2025, the USFDA published a revised guidance titled " Medical Device User Fee Small Business Qualification and Determination "...

On 25 July 2025 , the European Medicines Agency (EMA) published the latest guidance " Procedural Advice on Paediatric Applications " ....

In May 2025, the FDA, as part of the International Council for Harmonisation (ICH), endorsed and released for consultation the draft E21...

The European Medicines Agency (EMA) continuously updates its Good Pharmacovigilance Practices (GVP) guidelines to enhance patient privacy...

On 24 July 2025 , the UK Government published the latest update to its official guidance: " Regulation of medical devices in Northern...

On 22nd July 2025, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) released the Third Edition, Tenth Revision of the " Drug...

The U.S. Food and Drug Administration (FDA)  has launched the " Commissioner’s National Priority Voucher (CNPV) Pilot Program " a...

On 14 July 2025 , the European Medicines Agency (EMA) published the final revised guideline  titled " Guideline on the requirements for...

The Central Drugs Standard Control Organization (CDSCO)  under India’s Ministry of Health & Family Welfare has released a detailed...

The Central Drugs Standard Control Organisation (CDSCO) has published a fresh guidance document titled “ Guidance Document for Issuance...

On 18 July 2025, the European Commission published detailed Guidelines on the scope of the obligations for providers of general-purpose...

In a world where artificial intelligence (AI) is moving rapidly from theory to practice, regulators are tasked with keeping pace—not only...

In July 2025, the U.S. Food and Drug Administration (FDA) published its updated guidance for industry titled “ Formal Meetings Between...

The European Medicines Agency (EMA) provides structured guidance for sponsors aiming to secure orphan medicinal product designation...

In July 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released updated and expanded guidance on the use of...

The efficient international supply of medical devices depends not only on innovation but on robust regulatory processes that certify...

In the ever-evolving regulatory landscape of EU pharmaceuticals, digital solutions are a linchpin for timely and transparent scientific...

In an era of rapid pharmaceutical innovation, global collaboration is key to expediting patient access to new therapies. To help patients...