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Type IA Variations: Why "Simple" Variations Are Never as Simple as They Look
Ask any experienced regulatory affairs professional about Type IA variations and most will tell you the same thing: they look easy, they are not. Known in the industry as "do and tell" procedures, Type IA variations represent the process by which pharmaceutical companies make minor changes to their marketing authorisation (MA) dossiers — implementing the change first, then notifying the relevant regulatory authority. No prior approval needed. In theory, this is the most strai
Jun 2314 min read



