Regulatory Blog

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...