The US FDA releases Guidance: Permanent Discontinuance or Interruption in Manufacturing of Finished Products & API
On April 2023, the USFDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released a draft guidance on “Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act” that helps to prevent and mitigate drug shortage.
Overview FDA facilitates the management of post approval CMC to harmonize regulatory approval of drugs with ICH Q12 guideline. This guidance applies to pharmaceutical drug substances and products (both chemical and biological) that require a marketing authorization and to drug-device combination products that meet the definition of a pharmaceutical or biological product. Regulatory tools and […]
GRP Blog breaks down frequently asked regulatory questions pertaining to biologic registration in Mexico with Health Authority COFEPRIS
Trying to register your biologic in Brazil? Read GRP’s blog to get a greater understand of the regulations, pathways and timelines.
CDE releases No. 94 of 2018 stating that certain biological products maybe imported for a one- time for clinical trial purposes.