PIC/S Opens Consultations on Manufacturing ATMPs, Biological Medicinal Substances

International – PIC/S Opens Consultations on Manufacturing ATMPs, Biological Medicinal Substances

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is seeking comments on revisions to two parts of its GMP Guide (Annex 2A and Annex 2B) that...
FDA Collaborates With Health Canada, Australia to Approve New Cancer Drugs

International – FDA Collaborates With Health Canada, Australia to Approve New Cancer Drugs

The U.S. Food and Drug Administration is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework...
Médicaments : quelle(s) réalité(s) ?

International – Médicaments : quelle(s) réalité(s) ?

Le blog Rédaction Médicale et Scientifique a publié pas moins de 17 billets durant le mois d'août 2019 avec des données réalistes sur les...
Two New FDA, HHS Plans to Allow Drug Importation From Canada, Overseas

International – Two New FDA, HHS Plans to Allow Drug Importation From Canada, Overseas

As part of plans to lower the cost of prescription drugs, the US Department of Health and Human Services (HHS) and the Food and...
Information Note Nitrosamine impurities

International – WHO Revises Guidance on QMS Requirements for National Inspectorates

The World Health Organization (WHO) has revised its guidance on quality system requirements for national good manufacturing practice (GMP) inspectorates to align with international...
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...
European Commission : Technical Guidance on UDIs

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....
Information Note Nitrosamine impurities

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...
Information Note Nitrosamine impurities

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...

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