Regulatory Blog

The South African Health Products Regulatory Authority (SAHPRA) has issued a Communication to the industry on the process for the...

Malaysia’s Drug Registration Guidance Document (DRGD) is a cornerstone for pharmaceutical compliance. The " Drug Registration Guidance...

Health Canada has released detailed guidances addressing the validation rules for regulatory transactions submitted in two formats: "...

The European Medicines Agency (EMA) provided detailed revised guidance "Procedural Advice for Orphan Medicinal Product Designation " for...

Swissmedic has published an updated guidance for" Orphan Drug " aimed at streamlining the regulatory process for medicinal products...

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On 07 January 2025, the U.S. Food and Drug Administration (FDA) released the draft guidance titled " Developing Drugs for Optical Imaging...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) has recently issued several key guidance documents addressing critical areas in...

The U.S. Food and Drug Administration (FDA) released a draft guidance earlier today (07 January, 2025) outlining " Considerations for...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The US Food and Drug Administration (FDA) has released the Draft Guidance document titled " Considerations for Complying with 21 CFR...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The U.S. Food and Drug Administration (FDA) recently released (26 December 2024) draft guidance titled “ Protocol Deviations for Clinical...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 Medicines and Healthcare Products Regulatory Agency (MHRA)  has published updated guidance " Applying for a Licence to Market a...

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