Regulatory Blog

Introduction – EU Implementation Guide Following the publication of version 2.0 in February 2021, the content of sections 2. Chapters and...

This is a recently updated guidance that discusses How to apply for a clinical trial including eligibility, phases, model IMPDs, costs,...

FDA issued final guidance on June 21, 2021 to aid applicants of certain licensed biological products to determine the appropriate...

eCTD and NeeS are the standard electronic submission formats and allow the Common Technical Document (CTD) structure to be provided in an...

This guidance and the technical specifications document it incorporates by reference describe the requirements for electronic submission...

Medical devices encompass a vast array of products with different technologies, product lifecycles, complexity, intended users, and...

Product labels and the package leaflet play an essential part in the safe and effective use of the medicine by both the patients and...

Computerised systems are being increasingly used in clinical research. The complexity of such systems has evolved rapidly during the last...

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was established in 1995 as an extension to the Pharmaceutical Inspection...

This is a DRAFT GUIDANCE distributed for comment purposes only. This guidance provides recommendations to sponsors for the collection of...

The European Medicines Agency (EMA) on 8th June 2021 launched a stakeholder consultation on a draft EU common standard for electronic...

On June 1-2021, Clinical Data Interchange Standards Consortium (CDISC) confirmed that CDISC is teaming up with Microsoft to develop the...