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China’s CMC Harmonization Efforts Provide Opportunities for Industry Input

The China State Food and Drug Administration (SFDA) initiative to adopt selected international guidelines offers significant opportunities for industry to work closely with the agency to help it move toward a more science and risk-based approach to its CMC review process in line with the ICH model, industry regulatory experts are stressing....

Australia’s TGA Proposes Adoption of Several EU/ICH Guidelines

Australia’s Therapeutic Goods Administration (TGA) is requesting comment on its proposed adoption of several EU and ICH guidelines, and “non-adoption” of one.  The comment period closes on November 9. The following guidelines are proposed for adoption: ● ICH Topic Q3C (R4) Impurities: Guideline for Residual Solvents ● ICH Guideline Q4B Annex 12 to Note for […]

EMA’s IMP Guideline Will Provide Shelf-Life Flexibility and EU Harmonization

Two key thrusts of EMA’s “Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials” will be to provide flexibility in shelf-life determination for IMPs and to facilitate harmonization of the clinical trial application process across the EU....

Nanotechnology Under the Microscope at FDA

The rapidly expanding use of nanotechnology in therapeutic formulations is driving FDA to better define the regulatory and analytical framework needed to assess and address the potential concerns involved....
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