SQA

JULY 8, 2022

SQA Regulatory Surveillance Summary 2022 – May. Health Canada. Health Canada, Non-Compliant Drug Inspections, 1Q 2022. inspected on 25 January 2022: findings relate to premises, manufacturing control, quality control, sanitation, stability, raw material testing, equipment, and records ( West Penetone Inc.

Pharmaceutical Industry 40

Pharmaceutical Industry FDA Hospitals World Health 40

SQA

FEBRUARY 15, 2023

Relevant matters are hereby announced as follows: As of 01 December 2022, the Electronic Certificates of Documentation for Export of APIs to the EU and Certificate of a Pharmaceutical Product will be put into use. Efforts should be made to promote and guide the use of electronic certificates.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

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

AUGUST 8, 2023

In August 2022, ANVISA published Resolution RDC 741/2022 , which sets the framework to consider other medical device market regulators’ authorizations. mg Strengths) Due to Possible Device Failure, 05 May 2023 Bausch Health, Canada Inc. The affected lots of Emerade were distributed in Canada between April 2022 and May 2023.

FDA 40

FDA Compliance COVID-19 World Health 40

SQA

OCTOBER 18, 2023

National Medical Products Administration (NMPA) China GLP Certification Regulation Takes Effect, 01 July 2023 After consulting on the draft in 2022, the NMPA issued the Administrative Measures for Drug Good Laboratory Practice (GLP) Certification earlier this year.

FDA 40

FDA Compliance Licensing World Health 40

SQA

OCTOBER 18, 2022

SQA Regulatory Surveillance Summary for July and August 2022. Health Canada. Counterfeit COVID-19 Antigen Rapid Test Kits Found in Ontario, 05 August 2022. Health Canada is warning consumers about counterfeit BTNX Rapid Response COVID-19 antigen rapid test kits (25-pack boxes) found in Ontario. Taro Pharmaceuticals Inc.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 Compliance 40

SQA

FEBRUARY 26, 2024

Ltd, a Contract Research Organization (CRO) in Kharadi, India, was subject to a Good Clinical Practice (GCP) inspection in November 2020 and November 2022 by the Spanish Agency for Medicines and Medical Devices (AEMPS).

FDA 52

FDA Compliance COVID-19 Public Health 52