##  [Regulatory Roundup - Sep 02, 2024](/index%2Ephp/regulatory-roundup/week-of-sep-02-2024) 

[Back to Regulatory Roundup Archive](/regulatory-roundup)



## Top Industry News

- [From 1 September 2024, Swissmedic will Accept SEND Data Sets for Applications for New Authorisation of Human Medicinal Products with New Active Substances](https://www.swissmedic.ch/swissmedic/de/home/humanarzneimittel/authorisations/informationen/send-datensaetze-na-neue-ws.html)
- [SFDA Guideline on Good Pharmacovigilance Practices (GVP)](https://www.sfda.gov.sa/sites/default/files/2024-09/GuidelineGoodPharmacovigilancePractices.pdf)
- [ANVISA - Companies Must Submit Drug Marketing Report](https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/empresas-devem-enviar-relatorio-de-comercializacao-de-medicamentos-1)
- [Notify MHRA About a Clinical Investigation for a Medical Device](https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device)
- [COFEPRIS National Reference Laboratory Renews Certifications in Quality Management](https://www.gob.mx/cofepris/articulos/laboratorio-nacional-de-referencia-de-cofepris-renueva-certificaciones-en-gestion-de-calidad)
- [Swissmedic will Accept Electronic Data Sets from Pivotal Bioequivalence Studies](https://www.swissmedic.ch/swissmedic/de/home/humanarzneimittel/authorisations/informationen/elektronische-datensaetze-pivotaler-bioauquivalenzstudien.html)
- [The Ministry for Primary Industries has issued guidance on China's requirements for solid beverage products](https://www.mpi.govt.nz/dmsdocument/64734-Guidance-document-China-requirements-for-solid-beverages-powdered-products-for-drinking)
- [FSANZ - A1290 - Citicoline as a Nutritive Substance for Use in Formulated Caffeinated Beverages](https://www.foodstandards.gov.au/sites/default/files/2024-02/A1290%20Admin%20Assessment%20Report.pdf)
- [The Australia New Zealand Food Standards Code is being amended to permit the use of Agaricus bisporus as a source microorganism for chitosan in alcoholic beverage production, including wine, beer, cider, spirits, and other alcoholic beverages](https:/www.foodstandards.gov.au/sites/default/files/2024-08/A1306%20Executive%20Summary.pdf)
- [FSANZ has approved amendments to the Australia New Zealand Food Standards Code to correct a typographical error and remove a redundant term related to "no added sugar(s)" claims, following updates made under Proposal P1062](https://www.foodstandards.gov.au/sites/default/files/2024-08/P1063%20Approval%20Report.pdf)
- [Health and Safety Executive (HSE) has published a technical report proposing mandatory classifications for tea tree extract and oil under the GB Classification](https://www.hse.gov.uk/chemical-classification/assets/docs/mcl-aaqd-0684.pdf)
- [UK Product Safety Database Alerts July 2024](https://www.gov.uk/guidance/product-recalls-and-alerts)



## Upcoming Events

- [9th International Conference on Future Pharma and Innovations](https://futurepharmameetings.pharmaceuticalconferences.com/)

## Blogs

- [How Streamlining Your Communication Can Make or Break Your eCTD Submission](https://www.freyrsolutions.com/blog/how-streamlining-your-communication-can-make-or-break-your-ectd-submission)
- [Regulatory Requirements for Plant-Based and Vegan Food Products in New Zealand](https://www.freyrsolutions.com/blog/regulatory-requirements-for-plant-based-and-vegan-food-products-in-new-zealand)
- [ISO 13485:2016 Requirements on Quality Management Systems](https://www.freyrsolutions.com/blog/iso-134852016-requirements-on-quality-management-systems)
- [Understanding Health Canada’s Regulations for Class I Medical Devices](https://www.freyrsolutions.com/blog/understanding-health-canadas-regulations-for-class-i-medical-devices)
- [Simplifying Market Entry: Brazil's Recognition of Foreign Regulatory Approvals](https://www.freyrsolutions.com/blog/simplifying-market-entry-brazils-recognition-of-foreign-regulatory-approvals)
- [Comprehensive Guide to Post-Market Clinical Follow-Up (PMCF) Under EU MDR 2017/745Comprehensive Guide to Post-Market Clinical Follow-Up (PMCF) Under EU MDR 2017/745](https://www.freyrsolutions.com/blog/comprehensive-guide-to-post-market-clinical-follow-up-pmcf-under-eu-mdr-2017745)