الصحة و الدواء لحياة افضل

  Manufacturing Site Requirements for Drug Registration in the UAE When registering a drug in the United Arab Emirates (UAE), one of the key aspects evaluated by the Ministry of Health and Prevention (MOHAP) is the manufacturing site where the drug is produced. The UAE places strict quality assurance standards to ensure that all imported or locally manufactured pharmaceutical products meet international safety and efficacy guidelines. Below are the key requirements and considerations for the manufacturing site in the drug registration process: 1. Good Manufacturing Practice (GMP) Certification The manufacturing site must hold a valid GMP certificate issued by the health authority of the country of origin or recognized international regulatory bodies (e.g., FDA, EMA, TGA, WHO). GMP certification should be current and cover the specific product forms (e.g., tablets, syrups, injectables). MOHAP may request an on-site inspection if GMP compliance is in doubt or if the fa...