News

May 2021
Real Regulatory Tips and Insights

published 14 Jun 2021

The tips we published in May 2021 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

COVID-19 Restrictions & Validity of MIAs, WDAs, GMP & GDP Certificates

http://eudragmdp.ema.europa.eu/inspections/displayWelcome.do

EMA QRD Guidance Documents

https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information/product-information-reference-documents-guidelines

 

EMA Guidance on CSR Signatures and Appendices

https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-inclusion-appendices-clinical-study-reports-marketing-authorisation-applications_en.pdf

https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-coordinating-investigator-signature-clinical-study-reports_en.pdf

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