Saudi Arabia Gives Instructions for Site Master Files

Drugmakers that want to make products in Saudi Arabia should submit a site master file to the Saudi Food and Drug Authority (SFDA) with the names, dosage forms and product licenses of all drugs manufactured at a plant, a draft guidance says. Manufacturers also should note in the submission whether toxic or hazardous substances are manufactured at the site and whether the products are for human use, the SFDA says.
International Pharmaceutical Regulatory Monitor