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Dec 5, 20212 min read

Guidance on QPPV including Pharmacovigilance System Master Files– MHRA

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

Nov 30, 20211 min read

Draft Guidance on Assessing Registries to Support Regulatory Decision -USFDAYesterday, the USFDA

Yesterday, the USFDA issued draft guidance for the industry titled Real-World Data: Assessing Registries to Support Regulatory...

Nov 28, 20212 min read

Guidance for Declaration of Conformity - TGA

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

Nov 20, 20211 min read

MHRA’s updated Guidance on URGENT SAFETY MEASURE – UK

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

Nov 14, 20211 min read

Pharmaceutical Reference Standard – Guidance Update - SFDA

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

Nov 14, 20211 min read

Post-Authorisation Procedural Advice for Users of the Centralised Procedure – Updated guideline EMA

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

Nov 7, 20211 min read

Knowledge aided Assessment and Structured Application (KASA) Initiative

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

Nov 7, 20211 min read

Draft Guidance for Device Software in Premarket Submissions - USFDA

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