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May 4, 20211 min read

Finalized Guidance on Parallel MAA, EU-M4all procedure -EMA

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

May 4, 20211 min read

FDA Offers guidance on Generic Drug Development- COVID

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

May 3, 20212 min read

EU IDMP Implementation Guide - version 2.0

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

Apr 10, 20211 min read

Submitting data in the eCTD format - Therapeutic Goods Administration - Australia

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

Apr 10, 20211 min read

Submitting data in the NeeS format - Therapeutic Goods Administration -Australia

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