WHO Drafts Policy on Designating Regulators as Listed Authorities

International – Information Note Nitrosamine impurities

Background Medicine Regulatory Authorities first became aware of the presence of the nitrosamine impurity, Nnitrosodimethylamine (NDMA), in products containing valsartan in July 2018. Valsartan is...
ICH Updates After Singapore Assembly Meeting

International – ICH Updates After Singapore Assembly Meeting

The International Council for Harmonisation (ICH) on Wednesday provided an update on some of the milestones achieved following the ICH Assembly meeting in Singapore...
WHO Drafts Guideline on Data Integrity for Pharmaceuticals

International – WHO Drafts Guideline on Data Integrity for Pharmaceuticals

The World Health Organization (WHO) recently drafted a new guideline on data integrity that explains the important elements to ensure the reliability of data...
FDA’s Project Orbis May Expand to Singapore and Switzerland

International – FDA’s Project Orbis May Expand to Singapore and Switzerland

The US Food and Drug Administration (FDA) may expand a pilot project that allows for simultaneous drug approval decisions from US, Canadian and Australian regulators to include Singapore...
WHO Drafts Policy on Designating Regulators as Listed Authorities

International – WHO Seeks to Expand Access to Insulin With Prequalification Program

As only about half of the 65 million people worldwide with Type 2 diabetes who need insulin can access it, the World Health Organization...
ICH Updates After Singapore Assembly Meeting

International – ICH Survey Shows Wide Adoption of Guidelines Among Regulators, Industry

A recently released survey from the International Council on Harmonisation (ICH) shows pharmaceutical regulators and companies around the world are adopting and adhering to...
ICH Updates After Singapore Assembly Meeting

International – ICH Updates: What to Expect Through 2020

At a joint public consultation in Ottawa on Monday, officials from Health Canada and the US Food and Drug Administration (FDA) gave an overview...
Evolving Global Regulatory Landscape, Strategies and Best Practices

International – Evolving Global Regulatory Landscape, Strategies and Best Practices

October feature articles reported on a number of timely issues facing regulatory professionals today, including the advantages of using periodic safety update reports, practical...
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...

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