Top 9 Companies in the Diagnostics Market

International – Top 9 Companies in the Diagnostics Market

Add some market clearances; a rebranding; a merger or two; and some collaborations; and you’ve got a recipe for some of the most powerful...
Questions & Answers on the impact of Mutual Recognition Agreement between the European Union and the United States

International – Questions & Answers on the impact of Mutual Recognition Agreement between the...

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...
Le Plan Juncker soutient la recherche dans le traitement des maladies orphelines en France

International – EU-U.S. trade talks: milestone reached in mutual recognition on pharmaceuticals

Today, the European Union and the United States delivered on a significant element of the Joint Statement agreed by Presidents Juncker and Trump in July 2018....
WHO’s five-year plan to help build effective and efficient regulatory systems

International – WHO’s five-year plan to help build effective and efficient regulatory systems

WHO’s 2019–2023 Plan to help build effective and efficient regulatory systems is designed to help national regulators to deliver regulation that protects the public...
WHO’s five-year plan to help build effective and efficient regulatory systems

International – WHO Updates Lists of Essential Medicines, Diagnostics

The World Health Organization (WHO) on Tuesday released the latest lists of essential medicines and essential in vitro diagnostic (IVD) tests, which can help countries prioritize...
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...
WHO’s five-year plan to help build effective and efficient regulatory systems

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...

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