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.
