Information from the: EMA. ECA and EDQM

EMA

 ICH M9 on biopharmaceutics classification system based biowaivers

https://www.ema.europa.eu/en/ich-m9-biopharmaceutics-classification-system-based-biowaivers

 

Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)

https://www.espl-regulatory.com/wp-content/uploads/attachments/european-medicines-agency-pre-authorisation-procedural-advice-users-centralised-procedure_en-0-8.pdf

 

Quality of medicines questions and answers: Part 1 (updated)

https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/qa-quality/quality-medicines-questions-answers-part-1

 

Other: European authorities working to avoid shortages of medicines due to Brexit – Questions and answers (updated)

https://www.espl-regulatory.com/wp-content/uploads/attachments/european-authorities-working-avoid-shortages-medicines-due-brexit-questions-answers_en-9.pdf

  ECA

 Falsified Medicines: New EU Aide Memoire for GDP

https://www.gmp-compliance.org/gmp-news/falsified-medicines-new-eu-aide-memoire-for-gdp

  EDQM

 Pharmeuropa Volume 32 No 1, January 2020

https://www.edqm.eu/en/news/pharmeuropa-volume-32-no-1-january-2020

 

European Pharmacopoeia revises general chapter on degree of coloration of liquids

https://www.edqm.eu/en/news/european-pharmacopoeia-revises-general-chapter-degree-coloration-liquids

 

Ph. Eur. Supplement 10.2: CEP holders are invited to update their applications

https://www.edqm.eu/en/news/ph-eur-supplement-102-cep-holders-are-invited-update-their-applications

 

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