Pharmaceutical Excellence: Regulatory, Projects, & Programs
"Did you know that using a CEP-certified API can streamline your drug product approval process? 🤯 Learn more about regulatory sources for API manufacturers in this carousel. Links to the resources mentioned are in the comments! #API #CEPs #DrugApproval 📍 What are your go-to resources for finding reliable API suppliers? ❓ Why do you think the US Pharmacopeia dosen't have a project as the CEP project of the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe? ✍ Share your thoughts and any brilliant questions you have below! 👇 Let's learn from each other's expertise. #PharmaceuticalIndustry #KnowledgeSharing P.S. If you find this post useful, don't forget to share it with your network! 널리 알려주세요! 🇰🇷 Kongsikan dengan rangkaian anda! 🇲🇾 ¡Compártelo con tu red! 🇪🇸 अपने नेटवर्क के साथ साझा करें! 🇮🇳 分享给你的网络! 🇨🇳" FDA SFDA - هيئة الغذاء والدواء
Europe focuses on harmonization, while the US takes a risk-based oversight approach. Europe (CEP) follows a proactive model with pre-approval stamps, ensuring compliance from the start and simplifying approvals across 40+ countries. US (DMF) is reviewed only when linked to a drug application, allowing more flexibility while holding sponsors accountable.
Very informative
Thank you
Actually, I don't know why the US FDA didn't go through the same project as EDQM 🤔 GOOD question, but I have not the answer !!!
Thanks Alaa Elkazak, Msc., RAC-Drugs, PMP, CMQ-OE for your informative post, Actually, the main source of finding my APIs is the previous experience about the supplier itself and usually needs to qualify each supplier for each API.
Pharmaceutical Excellence: Regulatory, Projects, & Programs
8mohttps://sfda.gov.sa/en/informationlist/65634