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 agencies […]
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 […]
SQA Regulatory Surveillance Summary | Monthly Update 2023 – March And April
SQA Regulatory Surveillance Summary for March and April 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) ANVSA Recommends Intensification of Actions Against Arboviruses, 22 March 2023 ANVISA has published Technical Note 12/2023 which recommends the intensification of measures or the reduction of mosquito breeding sites and control of […]
SQA Regulatory Surveillance Summary | Monthly Update 2023 – February
SQA Regulatory Surveillance Summary for February 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA Releases the Results of the 2022 Strategy, 31 January 2023 The ANVISA Strategy Performance and Results Evaluation Report is now available for consultation, for the year 2022. The document details the evaluation of […]
SQA Regulatory Surveillance Summary | Monthly Update 2023 – January
SQA Regulatory Surveillance Summary for January 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner China: National Medical Products Administration (NMPA) NMPA Announcement on putting into use the electronic certificates of Documentation for Export of Active Pharmaceutical Ingredients (APIs) to the European Union (EU) and Certificate of a Pharmaceutical Product (No. 95, 2022), 08 November […]
SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October
SQA Regulatory Surveillance Summary for September and October 2022 Agência Nacional de Vigilância Sanitária (ANVISA) 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. The 20-page Q&A document covers general and specific topics including the importation of cannabis products, […]