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eCTD Industry Update (4th October 2022)

October 4, 2022
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EMA:

Orphans: Regulatory and procedural guidance and forms (updated): https://bit.ly/3mNjzfG

Product-information templates - Human (updated): https://bit.ly/3SQI61z

Template or form: QRD product-information template version 10.3 (updated): https://bit.ly/3SyQu61

Template or form: QRD product-information annotated template (English) version 10.3 - highlighted (updated):
https://bit.ly/3SvM2Vz

Template or form: QRD product-information annotated template (English) version 10.3 (updated):
https://bit.ly/3y70gE7

Template or form: QRD Appendix V - Adverse-drug-reaction reporting details (updated): https://bit.ly/3fC4q0G

Template or form: Specimen submission form (updated): https://bit.ly/3ydFnHz

Regulatory and procedural guideline: Checking process of mock-ups and specimens of outer/immediate labelling and package leaflets of human medicinal products in the centralised procedure (updated):
https://bit.ly/3STWZjQ

 

FDA:

FDA is announcing the expansion of the CDER NextGen Portal to enable certain electronic over-the-counter (OTC) monograph submissions to FDA under section 505G of the Federal Food, Drug, and Cosmetic Act.

PreveCTD Industry Update (28th September 2022)
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