Pre-Authorisation Procedural Advice for Users of the Centralised Procedure - EMA
Guideline on Quality Documentation for Drug-Device Combination Products - EMA
ICH Q13 Draft Guideline reaches Step 2 of the ICH process
FDA’s revised MAPP Procedures for Generic Drug Labeling Change
Guidance on Packaging for Human Medicinal Products, Med.Prod Names & eSubmissions platform - Swiss
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) – EMA
Latest reforms to Post-Market Monitoring of Medical Devices- Australia’s TGA
Draft guidance for Transdermal Adhesion Systems– US FDA
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