Da Yu Protein Sciences – Useful Links
ICH Guidelines - The unification of diverse regulatory requirements from national health agencies for drug development began in 1990 with the initiation of the International Conference on Harmonisation (ICH). The ICH, now known as the International Council for Harmonisation, has the mission of ensuring safe and effective drugs that are of the highest quality obtain global registration in the most efficient manner. Towards this end, the ICH publishes guidelines to achieve this objective. The current ICH guidelines are available at www.ICH.org.
FDA Guidance for Industry - Food and Drug Administration (FDA) Guidances cover the agency's most recent thinking on a particular regulatory topic. Although most of these guidances can be interpreted as recommendations, it may be a prudent strategy for drug development sponsors to adhere to these recommendations as if they were requirements. Current FDA Guidances are available at FDA Guidances.
Specific links to FDA Guidances relevant to Biologics development include the following:
- Analytical Procedures and Method Validation for Drugs and Biologics.
- cGMP for Phase I Investigational Drug.
- Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing and Controls Information.
- Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.
EMA Guidances - The European Medicines Agency (EMA) pubilishes Biological Guidelines to assist sponsors preparing marketing authorization dossiers for Biologics intended as human medicines.
For any assistance in the CMC development of Biologics clents are encouraged to Conctact Us.