Regulatory Blog

UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on requesting a pharmacovigilance system master file...

Yesterday, the USFDA issued draft guidance for the industry titled Real-World Data: Assessing Registries to Support Regulatory...

When applying for inclusion in the Australian Register of Therapeutic Goods (ARTG), different classes of medical device require different...

This guidance has been developed to assist those involved in clinical trials disrupted as a result of COVID-19. It is relevant to those...

Standards and reference substances play a vital role in evaluating the quality of active pharmaceutical ingredients and finished...

This guidance document addresses a number of questions that marketing authorisation holders (MAHs) may have on post-authorisation...

The current challenges with the eCTD system that the agency currently uses, explaining how it does “not follow the development flow of...

This guidance document is intended to provide information regarding the recommended documentation sponsors should include in premarket...