The EU Variations Guideline and the SAHPRA Variations Addend…

The EU Variations Guideline and the SAHPRA Variations Addendum provide procedural guidance on how to classify and submit regulatory changes. When determining the regulatory requirements for a post-approval amendment, which other type of guidelines must be considered to ensure that the change meets all regulatory expectations?

A pharmaceutical company submits an application for registra…

A pharmaceutical company submits an application for registration of a new chemical entity (NCE) in South Africa. The dossier includes only quality (CMC) data, with limited preclinical and no clinical data, based on the assumption that international literature will be sufficient. Which of the following statements is most accurate regarding the data requirements for registration?