Safety Observer 217
ICH has published Annex 2 of the E6(R3) draft Guideline on GCP for public consultation.
Report 217 — Highlights
ICH E6(R3): Annex 2
Further to the publication of the first parts of the E6(R3) draft Guideline in May 2023, ICH has now published Annex 2 for public consultation, which provides additional GCP considerations.
FDA Guidance: CGT products
The FDA has published a new draft guidance, which provides answers to a list of questions relevant to the development of cellular and gene therapy (CGT) products.
FDA Guidance: Ovarian Toxicity
The FDA has published a new draft guidance entitled “Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products”.
Pakistan: PV Guidelines
The Drug Regulatory Authority of Pakistan (DRAP) has now published the final version of its revised Guidelines on National Pharmacovigilance System (3rd Edition).
India: PV Guideline for MAHs
Further to the publication of the revised Pharmacovigilance Guidance on 17-Sep-2024, the Ministry of Health of India has now announced that it will become effective on 01-Feb-2025.
