Providing Regulatory Submissions in Alternate Electronic Format – US FDA
Five Drugs as Preferred for COVID-19 Therapeutics - listed by EMA
Clinical trials: Apply for authorisation in UK – MHRA
Australian electronic Submission Basics Guide- Australia (TGA)
Guidance on Providing Regulatory Submission in e-Format for Standardized Study Data -US FDA
Guide to Labels and Leaflets of Human Medicines- IRELAND (HPRA)
Open Consultation for EU common standard on electronic product information- EMA
FDA Guidance regarding Onsite Inspections during COVID19 (Q&A) - USA
ANDAs for Certain Highly Purified Synthetic Peptide Drug Products
Guidance on the Licensing of Biosimilar Products - United Kingdom (MHRA)
Guidance-Implementation of Decentralised Elements in Clinical Trials–Denmark-Danish Medicines Agency
Guidance documents for Therapeutic Products (e-labelling) – SINGAPORE
Finalized Guidance on Parallel MAA, EU-M4all procedure -EMA
FDA Offers guidance on Generic Drug Development- COVID
EU IDMP Implementation Guide - version 2.0
Submitting data in the eCTD format - Therapeutic Goods Administration - Australia
Submitting data in the NeeS format - Therapeutic Goods Administration -Australia