SQA

DECEMBER 16, 2022

SQA Regulatory Surveillance Summary for September and October 2022. ANVISA’s Questions & Answers (Q&A) on Medical Cannabis for Clinical Investigations, 14 September 2022. ANVISA published answers to questions received during an online seminar on clinical research of medicinal cannabis held in May 2022. 30 of 2022.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

DECEMBER 10, 2021

NMPA Notice on Matters Concerning the Registration of Drug-device Combination Products, NMPA Newsletter, 27 July 2021. Guidance for Nomenclature for Generic Names of Medical Software, issued 12 July 2020. Guidance for Nomenclature for Generic Names of Respiratory, issued 12 July 2021. In-house devices.

FDA 52

FDA Compliance Public Health Hospitals 52

SQA

FEBRUARY 26, 2024

The action was held from 26 to 28 September 2023, at the city’s international entry points. On 08 November 2023, PIC/S sent a letter to NMPA confirming the applicant status. The applicants should also meet with CDE to undergo product-by-product analyses for the generics exempted from clinical trials.

FDA 52

FDA Compliance COVID-19 Public Health 52