eCTD submission

Submission of an updated Risk Management Plan (RMP) to TGA (Therapeutic Goods Administration) Australia

TGA has updated RMP for the sponsors of prescription medicines and biologicals making applications to enter or vary Australian Register of Therapeutic Goods (ARTG) entries. Therapeutic Goods Administration has provided form to be submitted along with updated RMP. Use this form when submitting an updated RMP after regulatory approval. This form should be submitted in […]

eCTD submission

Jordan Food & Drug Administration (JFDA) started eCTD submissions

Moving towards to the paperless submission of dossier, JFDA has started accepting submission in eCTD format Following the same all initial marketing authorization submission from 01.03.2019, need to be submit in Jo-eCTD format. For other submission types an announcement will be published later (a Baseline for already approved marketing authorisations will be required) Jordan (JO […]

Book a Demo