Regulatory Blog

The World Health Organization (WHO) has released the draft working document titled " Points to Consider in Continuous Manufacturing of...

The Pharmaceutical Inspection Co-operation Scheme (PIC/S)  has released its " Guidance on Remote Assessments " effective from January...

On 07 January 2025, the U.S. Food and Drug Administration (FDA) released the draft guidance titled " Developing Drugs for Optical Imaging...

The U.S. Food and Drug Administration (FDA) released a draft guidance earlier today (07 January, 2025) outlining " Considerations for...

Swissmedic, the Swiss Agency for Therapeutic Products, has recently updated its guidance documents for " Parallel Import " and "...

The US Food and Drug Administration (FDA) has released the Draft Guidance document titled " Considerations for Complying with 21 CFR...

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) continues to innovate in the regulatory space with updated processes...

The International Council for Harmonisation (ICH) continues to advance global standards in drug development and clinical practices with...

The U.S. Food and Drug Administration (FDA) recently released (26 December 2024) draft guidance titled “ Protocol Deviations for Clinical...

The European Medicines Agency (EMA) has issued comprehensive guidance " European Medicines Agency Pre-Authorisation Procedural Advice for...

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on the " Licensing of Biosimilar Products " in...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published (20 December 2024) updated guidance " Variations to...

The U.S. Food and Drug Administration (FDA) has released a guidance " Technical Specifications for Submitting Clinical Trial Data Sets...

The Medicines and Healthcare Products Regulatory Agency (MHRA)  has published updated guidance " Applying for a Licence to Market a...

The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER)  has unveiled an innovative initiative—the CDER...

The United States Food and Drug Administration (USFDA) has released detailed guidance" Standardized Format for Electronic Submission of...

The United States Food and Drug Administration (USFDA) has released (05 December, 2024) the draft guidance " Expedited Program for...

The US Food and Drug Administration (USFDA)  has released two insightful reports aimed at improving its internal practices and...

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has launched (4th December 2024) a groundbreaking pilot scheme "...

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has issued a Request for...