##  [Regulatory Roundup - Sep 16, 2024](/index%2Ephp/regulatory-roundup/week-of-sep-16-2024) 

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



## Top Industry News

- [Swissmedic Publishes New Regulatory Law Applies from 1 November 2024](https://www.swissmedic.ch/swissmedic/de/home/news/mitteilungen/verordnungsrecht-ab-1-nov-2024.html)
- [FDA Authorizes First Over-the-Counter Hearing Aid Software](https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-hearing-aid-software)
- [SAMR Opens Public Consultation on Front-of-Pack Nutrition Labeling Guidelines for Prepackaged Foods](https://std.samr.gov.cn/gb/search/gbDetailed?id=02DDAC68065BAD4CE06397BE0A0A1546)
- [FDA Guidance on ANDA Submissions - Amendments to Abbreviated New Drug Applications Under GDUFA](https://www.fda.gov/media/89258/download)
- [AMR is Opening a Public Consultation on General Guidance for Food Nutritional Facts](https://std.samr.gov.cn/gb/search/gbDetailed?id=02DDAC68065BAD4CE06397BE0A0A1546)
- [ANVISA New Standard Updated on Safety Requirements for Medical Devices Comes Into Force](https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/norma-sobre-requisitos-de-seguranca-para-dispositivos-medicos-entra-em-vigor)
- [MDlaw - The NANDO Database has a New Notified Body Under the IVDR](https://mdlaw.eu/ivdr/ivdr-13th-notified-body-on-nando/)
- [FDA Guidance on Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications](https://www.fda.gov/media/135373/download)
- [Singapore HSA Regulatory Update - Good Submission Practice 2024](https://www.hsa.gov.sg/docs/default-source/hprg-mdb/regulatory-updates/good-submission-practice-2024.pdf)
- [COFEPRIS Authorizes Sanitary Registration for the MPOX Vaccine](https://www.gob.mx/cofepris/articulos/cofepris-autoriza-registro-sanitario-a-vacuna-contra-mpox)
- [MHRA Guidance on Established Medicines: Marketing Authorisation Application Changes](https://www.gov.uk/guidance/established-medicines-marketing-authorisation-application-process-changes)
- [MHRA Performance Data for Assessment of Clinical Trials and Established Medicines](https://www.gov.uk/government/publications/mhra-performance-data-for-assessment-of-clinical-trials-and-established-medicines)
- [ECHA Urges SME Registrants to Verify Company Size to Avoid Penalties](https://echa.europa.eu/-/echa-to-sme-registrants-check-your-company-size)
- [ANVISA Creates Technical Chamber for Clinical Research of Medicines and Medical Devices](https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-cria-a-camara-tecnica-de-pesquisa-clinica-de-medicamentos-e-dispositivos-medicos-catepec)
- [FSANZ Invites Submissions on the Use of Prolyl Oligopeptidase as a Processing Aid](https://www.foodstandards.gov.au/food-standards-code/circulars/notification-circular-304-24)
- [FSANZ Calls for the Submissions on 2-MeOx as an Extraction Solvent Processing Aid](https://www.foodstandards.gov.au/food-standards-code/applications/Application-A1260-2-methyloxolane-as-a-processing-aid)



## Upcoming Events

- [World Drug Safety Congress EU 2024](https://www.terrapinn.com/conference/world-patient-safety-congress-europe/index.stm)

## Blogs

- [Ensuring Labeling Compliance: Key Considerations for Cosmetic Companies in LATAM](https://www.freyrsolutions.com/blog/ensuring-labeling-compliance-key-considerations-for-cosmetic-companies-in-latam)
- [Decoding Formulation Review and Product Classification: Expert Insights for Cosmetic Compliance in Canada](https://www.freyrsolutions.com/blog/decoding-formulation-review-and-product-classification-expert-insights-for-cosmetic-compliance-in-canada)
- [Good Manufacturing Practices in Philippines Cosmetic Businesses: Compliance Tips and Best Practices](https://www.freyrsolutions.com/blog/good-manufacturing-practices-in-philippines-cosmetic-businesses-compliance-tips-and-best-practices)