Top Industry News
- EMA - New guidance on type II variations and marketing authorisation extensions for orphan-designated medicines
- FDA-Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices
- SFDA-Temporary Requirements for Clearing Medical Devices and IVD Medical Devices
- South African Specification for eCTD Regional -Module1
- MCC-Implementation Guidance of South African eCTD Module 1 specification v2.1 and Validation Criteria v2.0
- MCC-Validation template for applications for registration in eCTD format
- MCC-Questions & Answers Implementation of eCTD in South Africa
- SFDA-Saudi Drug Code (SDC) and Drug Barcoding Specification
- EMA-Revising the guideline on first-in-human clinical trials
- Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products
- Consultations on adoption of European Union guidelines in Australia
- EMA-Modelling and simulation in the development of medicines