Regulatory Blog

US Food and Drug Administration (FDA) on 06-July-2021, finalized guidance on “Development and Submission of Near Infrared Analytical...

USFDA on 06-July-2021, finalized guidance on the use of metastasis-free survival (MFS) as an endpoint in clinical trials for...

Swismedic released multiple Guidance documents on 1st august, 2021 and are as follows 1. Guidance document Variations and extensions HMV4...

The French National Agency for Medicines and Health Products Safety (ANSM) has released guidance on the development of shortage...

This guidance document addresses a number of questions that users of the centralised procedure may have. It provides an overview of the...

The European Medicines Agency (EMA) on 22-July-2021 has adopted a guideline on the quality information that manufacturers of combination...

ICH on 27 July 2021, confirmed that the ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 2...

FDA on July 26, 2021, published a revision to the Manual of Policies and Procedures (MAPP 5230.3), “Generic Drug Labeling Revisions” The...

Guidance document Packaging for Human Medicinal Products HMV4 This guidance document explains how primary and secondary packaging...

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

A recent notice was published by Australia’s TGA details on the latest reforms to post-market monitoring of medical devices. The TGA...

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...

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

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...

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

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

After the publication of the Guidance for "Remote Interactive Evaluations", FDA has updated its "Manufacturing, Supply Chain, and Drug...