The impact of Mutual Recognition Agreement between the European Union and the United States as of 27 June 2019 : Questions & Answers

Europe – The impact of Mutual Recognition Agreement between the European Union and...

Q1: What is in place since 1 November 2017? A1: The provisions of the agreement relating to the mutual recognition of inspections took effect on...
WHO develops classification system for protecting efficacy of antibiotics

International – WHO develops classification system for protecting efficacy of antibiotics

The World Health Organization (WHO) launched a global campaign Tuesday to curb the spread of antibiotic resistant germs through safer and more effective use...
FDA Seeks Comment on ICH Guideline on Optimizing Safety Data Collection

International – ICH Adds Four New Regulatory Observers

Regulators from Argentina, Israel, Jordan and Saudi Arabia were recently approved by the International Council for Harmonisation (ICH) Assembly as Regulatory Observers. The approvals...
FDA Seeks Comment on ICH Guideline on Optimizing Safety Data Collection

International – ICH guideline E8 (R1) on general considerations for clinical studies : Step...

Clinical studies of medical interventions are conducted to provide information that can ultimately improve access to safe and effective drugs with meaningful impact on...
Information Note Nitrosamine impurities

International – WHO Outlines Process to Designate Regulators as WHO-Listed Authorities

As part of a shift from the term “stringent regulatory authority” to “WHO-Listed Authority” (WLA), the World Health Organization (WHO) in May discussed some...
L’OMS adopte une résolution sur la transparence du marché des médicaments

International – L’OMS adopte une résolution sur la transparence du marché des médicaments

Les États membres de l’Organisation mondiale de la santé (OMS) ont adopté, mardi 28 mai, une résolution demandant plus de transparence sur les marchés des médicaments, mais...
Study quantifies drug revenue invested in R&D

International – Study quantifies drug revenue invested in R&D

A coalition of the drug industry’s fiercest foes is accusing the world’s top drug makers of hiding behind research and development “as an excuse...
Information Note Nitrosamine impurities

International – WHO Stresses Role of GMP in Combatting Antimicrobial Resistance

The World Health Organization (WHO) issued a draft document Wednesday on environmental aspects of good manufacturing practices (GMP) to aid inspectors and manufacturers of...
Regulatory Intelligence: Update on Regenerative Medicine Advanced Therapies Designations

International – Regulatory Intelligence: Update on Regenerative Medicine Advanced Therapies Designations

This article discusses the scope and purpose of the special designation for Regenerative Medicine Advanced Therapies (RMAT) created by the passage of the 21st Century Cures...
FDA Seeks Comment on ICH Guideline on Optimizing Safety Data Collection

International – ICH Drafts Revised Guideline on General Considerations for Clinical Studies

With a focus on modernization, the International Council for Harmonisation (ICH) on Thursday released for public consultation a draft version of its guideline E8(R1)...

NOS PROCHAINES FORMATIONS