Regulatory Blog

The Medicines and Healthcare products Regulatory Agency (MHRA) is ensuring that the UK remains one of the best places in the world to...

European Medicines Agency (EMA) has assessed several rare adverse events for COVID-19 vaccines and one gene therapy for treating...

The Medicines and Healthcare products Regulatory Agency (MHRA) publishes its Delivery Plan 2021-2023 ‘Putting patients first. This Plan...

The MHRA phase I accreditation scheme is a voluntary scheme for organisations conducting phase I trials, for those conducting first in...

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced that its new guidance on good practices for data management and...

This guidance provides recommendations for clinical trials designed to assess the adhesion performance of transdermal and topical...

The US Food and Drug Administration on 1st-July,2021 issued final guidance to assist sponsors in using alternate electronic formats for...

The European Medicines Agency (EMA) has issued a list of five preferred therapeutics for COVID-19 patients, including four monoclonal...

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This is a DRAFT GUIDANCE distributed for comment purposes only.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...