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News dal mondo

04

Nov

Modernization of the FDA CDER Export Certificate Program

On Dec. 3, 2021, the FDA Center for Drug Evaluation and Research (CDER) will begin issuing electronic Certificates of Pharmaceutical Product (eCPPs) and will no longer issue or mail paper CPPs. CPP applications received prior to Dec. 3, 2021, will be issued as paper certificates. The eCPPs for human drug products will be issued as downloadable PDFs through the CDER Export Certification Application and Tracking System (CDER eCATS). The change from paper to electronic certificates will improve efficiency in issuing CPPs, reducing delivery time for export certificates and decreasing impact on the environment...[FDA]

18

Gen

AIFA - Gestione telematica istanze e atti emessi dall’Ufficio GMPMED. Avvio della I Fase dal 17 gennaio 2022

L’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (Ufficio GMPMED), allo scopo di ottimizzare...

14

Gen

“CEP of the future”: project update

The consultation phase of the project to design the Certificate of suitability to the monographs of...

13

Gen

Industry seeks delay for reporting manufacturing volume data

Drugmakers and active pharmaceutical ingredient (API) suppliers say they need more time to set up...

13

Gen

Pharmaron Acquires API Manufacturing Facility in UK from Recipharm

Continues to strengthen global chemistry and manufacturing capabilities and capacities.


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