Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

Jun 4, 20232 min read

SwissMedic Guidance: Orphan Drug, New Active Substance & Prior Notification

Swissmedic recently (02 June 2023) released multiple important guidelines that have captivated the audience and generated significant...

Oct 22, 20222 min read

UK MHRA Guidance: Register to Manufacture, Import or Distribute Act.Sub, & Reclassify Products

The Medicines and Healthcare products Regulatory Agency (MHRA) recently updated a few guidances related to registration &...

Oct 11, 20221 min read

MHRA Guidance: Export Drugs & Medicine, Active substances Manufactured in GB for use in EEA & NI

The Medicines and Healthcare products Regulatory Agency (MHRA) recently updated a couple of guidances related to Exporting active...

Jun 7, 20222 min read

Swissmedic - Guidance on known Active Pharmaceutical Substance & Time limits for Authorisation

Guidance Document Authorisation of the human medicinal product with known Active Pharmaceutical Substance Medicinal products with known...