Complex Generic Products: Insight of Current Regulatory Frameworks in US, EU and Canada and the Need of Harmonisation

Author:

Lunawat Sandeesha,Bhat Krishnamurthy

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Reference34 articles.

1. Holloway C, Mueller-Berghaus J, Lima B, Lee S, Wyatt J, Nicholas J, et al. Scientific considerations for complex drugs in light of established and emerging regulatory guidance. Ann N Y Acad Sci. 2012;1276(1):26–36. https://doi.org/10.1111/j.1749-6632.2012.06811.x.

2. Indian Pharma: Transitioning to Specialty Generics [Internet]. Yesbank.in. 2017. https://www.yesbank.in/pdf/indian_pharma_transitioning_to_specialty_generics.pdf. Accessed 12 Nov 2018.

3. Fda.gov. GDUFA II Commitment Letter. FDA- OGD; 2017 p. 14–17.

4. Oner Z, Michel S, Polli J. Equivalence and regulatory approaches of nonbiological complex drug products across the United States, the European Union, and Turkey. Ann N Y Acad Sci. 2017;1407(1):26–38. https://doi.org/10.1111/nyas.13505.

5. Uhl K. Complex Generic Drug Product Development Workshop Opening Remarks. Presentation Presented at; Complex Generic Drug Product Development Workshop, CDER SBIA; 2018.

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