Global Pharma Guidance Tracker – January 2018
Stay up to date on regulatory guidelines from around the world, with the Pink Sheet's Guidance Tracker
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The International Pharmaceutical Regulators Programme has documented various approaches currently being used for the clinical comparability of biosimilar monoclonal antibodies in different jurisdictions.
Remote inspections are here to stay, and global regulators are aligning efforts to develop consensus on how these should be conducted.
Device companies operating in Canada are being advised to review their internal procedures in anticipation of new postmarket requirements that come into force this year.