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SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

A new template for the Certificate of a Pharmaceutical Product will be put into use in line with China’s pharmaceutical export practices and the latest World Health Organization (WHO) guidelines. The electronic certificate and the paper version are equally authentic.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – July and August 2023

SQA

The measure, adopted through Resolution – RE 2910/2023 , was made after the Agency was informed by the Sanitary Surveillance of Goiás about the occurrence of serious adverse events associated with the incorrect use of the products.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – May And June

SQA

The new standard, RDC 786/2023 , was published in the Official Gazette on 10 May 2023 and will enter into force on 01 August 2023, but establishments will have up to 180 days to comply with the updated rules. The rules of RDC 786/2023 correspond to a normative update, which replaces RDC 302/2005.

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SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October

SQA

The changes will serve to strengthen the country’s medical device registration regulations upon their effective date of 01 March 2023. The new Annex 1 will begin on 25 August 2023 with the exception that the deadline for Chapter 8.123, “Product transfer/ loading/unloading areas for lyophilizers” is 25 August 2024.

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SQA Regulatory Surveillance Summary | Monthly Update 2022 – July/August

SQA

Policymakers, regulators, and legislators should not make any decisions that impact consumers’ access to FDA-approved sunscreen UV filters until the scientific community reaches an informed consensus. PIC/S Sub-Committees have been elected for a two-year term starting on 01 January 2022 and ending on 31 December 2023.

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SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

The action was held from 26 to 28 September 2023, at the city’s international entry points. ANVISA Publishes New Measures to Prohibit Cosmetic Products Used in Injectable Form, 10 October 2023 ANVISA published two resolutions that suspended the trade, distribution, manufacture, advertising, and use of products from PHD Cosméticos Ltda.

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