August 2021
Real Regulatory Tips and Insights

Since the beginning of July 2020, we have published weekly Regulatory tips and insights from our Regulatory experts on our Real Regulatory LinkedIn page, as a service to our followers. The tips we published in August 2021 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

EU CTIS: Go-Live Date and Transition Timings

Marketing Authorisation Application Form

MHRA COVID-19 Risk Assessment

Paediatric Development Plans in the US and Europe

LINK 1 : https://www.ema.europa.eu/en/human-regulatory/research-development/paediatric-medicines/paediatric-investigation-plans/paediatric-investigation-plans-questions-answers#1.-applying-for-a-pip,-waiver-or-deferral-section

LINK 2: https://www.fda.gov/media/86340/download