SQA Regulatory Surveillance Summary | 3Q/4Q 2025
Staying informed on the latest pharmaceutical compliance updates is essential for navigating an increasingly complex global regulatory landscape. From evolving GMP requirements and regulatory guidance to enforcement actions and emerging risks, these updates directly impact how organizations manage quality, ensure compliance, and protect patient safety. This summary highlights key developments across major health authorities and […]
SQA Regulatory Surveillance Summary for Q2 2025 | Pharmaceutical Regulatory News
This edition of the pharmaceutical regulatory news summary highlights key global developments impacting pharmaceuticals, medical devices, and compliance. The update covers enforcement actions, safety alerts, and regulatory guidance issued by major health authorities including ANVISA, FDA, EMA, NMPA, MHRA, Health Canada, WHO, and others, offering timely insight into evolving regulatory expectations worldwide.
SQA Regulatory Surveillance Summary for Q1 2025
Stay informed with SQA’s Q1 2025 Regulatory Surveillance Summary, featuring key updates from FDA, EMA, WHO, ANVISA, NMPA, and other global health authorities.
SQA Regulatory Surveillance Summary for 3Q/4Q 2024
Review key 2024 regulatory shifts still influencing 2025—covering pharma, medical devices, AI, cosmetics, and global compliance strategies.
SQA Regulatory Surveillance Summary for May and June 2024
SQA Regulatory Surveillance Summary for May and June 2024 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA will use Analysis of Equivalent Foreign Authorities for Inspection and GMP Certification Process, 03 May 2024 In the Official Gazette of the Union, ANVISA has published the Normative Instruction (IN) 292/2024, which […]
SQA Regulatory Surveillance Summary for March and April 2024
SQA Regulatory Surveillance Summary for March and April 2024 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Brazil: Agência Nacional de Vigilância Sanitária (Anvisa) Anvisa Extends the Validity Period of the Certificate of Good Manufacturing Practices to Four Years, 22 March 2024 The validity of the Certificate of Good Manufacturing Practices (CBPF or cGMP) of […]
SQA Regulatory Surveillance Summary for January and February 2024
SQA Regulatory Surveillance Summary for January and February 2024 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA Publishes New Edition of the Biovigilance Manual, 17 January 2024 In Brazil, biovigilance covers a set of monitoring and control actions, ranging from donation to the clinical evolution of a recipient […]
SQA Regulatory Surveillance Summary | Monthly Update 2024
SQA Regulatory Surveillance Summary for Quarter 4, 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) Joint Operation in Foz do Iguaçu Fights Illegal Import of Products Subject to Health Surveillance, 29 September 2023 ANVISA and the Federal Revenue Service carried out a joint operation in Foz do Iguaçu […]
SQA Regulatory Surveillance Summary | Monthly Update 2023 – July and August 2023
SQA Regulatory Surveillance Summary for July and August 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA Carries Out Health Inspection Actions in Food Supplement Industries in Rio de Janeiro, 10 July 2023 During the week of 12-16 June 2023, ANVISA and state and municipal health surveillance […]
SQA Regulatory Surveillance Summary | Monthly Update 2023 – May And June
SQA Regulatory Surveillance Summary for May and June 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) Understanding the New Rules for Clinical Analysis Laboratories, 12 May 2023 ANVISA has updated the standards that deal with the technical requirements for the operation of laboratories that perform collection, examination, and […]