Regulatory Blog

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...

Project Orbis is an innovative programme coordinated by the US Food and Drug Administration (FDA) with Canada, Australia, Switzerland,...

The International Coalition of Medicines Regulatory Authorities (ICMRA) and World Health Organisation (WHO) calls on the pharmaceutical...

Regulators from 11 agencies, representing the US, the UK, Spain, Germany, and Russia, discussed their views on these challenges and...

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...