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FDA (CDER): Generic Development and Bridging Global Regulations
Approximately 90 percent of prescriptions in the US are generics that often are the product of an intricate global supply chain. The Office of Generic Drugs (OGD) is involved in efforts to advance the international harmonization of scientific, technical and regulatory standards for generic drug development. OGD continues global efforts with a focus on prioritizing future topics for generic harmonization that will include more complex generic drugs. The envisioned outcome of these global efforts is reduced time and cost of product development, consequently improving patient access to more affordable medicines. OGD Global Affairs identifies opportunities and challenges as those national regulations are being developed and implemented positioning regulators proactively on the path of convergence.
1) FDA’s views on global harmonization of regulatory process for generic drugs
2) Identifying opportunities and challenges in arriving at harmonized processes globally.
-Dr Mathew Cherian, Executive Committee Member, Industrial Pharmacy Section, Consultant, USA
-Mr Desai Kaushik , Associate ExCo Member, Industrial Pharmacy Section (FIP), Secretary General, International Pharmaceutical Excipient Council of India, India
-Sarah Ibrahim, Director CDER, FDA, USA