Regulatory Blog

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...

The guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product...

What is a Biosimilar Medicine? Biosimilar medicine is a biological medicine that is developed to be highly similar and clinically...

The purpose of this guidance is to illuminate any challenging areas lacking solutions to sufficiently ensure trial participant's safety...

The Therapeutic Products Branch (TPB) finalized guidance on e-labelling of therapeutic products (TPs) in Singapore has been published and...

The European Medicines Agency (EMA) on 22 April 2021 released the final version of its guidance for parallel EU-M4all (Article 58) and...

US Food and Drug Administration (FDA) On April-5, 2021 released new questions and answers guidance for generic drug makers briefing...

EMA published the current version, version 2.0 (EU IG v2.0), in February 2021. It mainly serves to support the European medicines...

This information is for sponsors and manufacturers wanting to submit data in the electronic Common Technical Document (eCTD) format for...

This information is for sponsors and manufacturers wanting to submit data in the NeeS format for a: prescription medicine biological...