##  [Regulatory Roundup - July 22, 2024](/index%2ephp/regulatory-roundup/week-of-july-22-2024) 

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



## Top Industry News

- [ANSM - New European Regulation on Substances of Human Origin (SoHO)](https://ansm.sante.fr/actualites/nouvelle-reglementation-europeenne-sur-les-substances-dorigine-humaine-soho)
- [Guidance on Classification Rules for IVDs under Regulation (EU) 2017/746](https://health.ec.europa.eu/document/download/12f9756a-1e0d-4aed-9783-d948553f1705_en?filename=md_mdcg_2020_guidance_classification_ivd-md_en.pdf)
- [Commission Regulation (EU) 2024/1808 of 1 July 2024 Amending Regulation (EU) 2023/915 as Regards the Application Date of Lower Maximum Levels for Ergot Sclerotia and Ergot Alkaloids in Food](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32024R1808&qid=1720190036686)
- [Guidance on Standardisation for Medical Devices](https://health.ec.europa.eu/document/download/59ac4cb0-f187-4ca2-814d-82c42cde5408_en?filename=md_mdcg_2021_5_en.pdf)
- [FDA Guidance on Application User Fees for Combination Products](https://www.fda.gov/media/76413/download)
- [EU Safety Gate Alerts June 2024](https://www.ctpa.org.uk/news/eu-safety-gate-alerts-june-2024-7839)
- [Artificial Intelligence Act just published: Classification of AI medical devices and IVDs](https://mdlaw.eu/mdr/artificial-intelligence-act-just-published/)
- [ANVISA Provides Tool for Updating Provisional Drug Prices](https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-disponibiliza-ferramenta-para-atualizacao-de-precos-provisorios-de-medicamentos)
- [UK Update on OPSS product safety alerts and reports of cosmetic products posing a risk to the health and safety of consumers](https://www.ctpa.org.uk/news/uk-product-safety-database-alerts-june-2024-7836)
- [CDRH Announces Expansion of the Total Product Life Cycle Advisory Program](https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-expansion-total-product-life-cycle-advisory-program)
- [FDA Guidance on Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies](https://www.fda.gov/media/158178/download)
- [UGA/FDA 11th Annual Medical Device Regulations Conference](https://www.fda.gov/about-fda/office-medical-device-and-radiological-health-inspectorate-omdrhi/ugafda-11th-annual-medical-device-regulations-conference-08212024)
- [IFRA Letter Update:IL1187 + Attachment 01](https://www.ctpa.org.uk/news/ifra-letter-update-7844)
- [FDA Draft Guidance on Drugs for the Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and Older](https://www.fda.gov/media/130449/download)
- [Title 21/Chapter I/Subchapter B/Part 180/Subpart B/180.30 Brominated Vegetable Oil](https://www.ecfr.gov/recent-changes)



## Upcoming Events

- [Medical Information and Communications Conference](https://www.diaglobal.org/en/conference-listing/meetings/2024/09/medical-information-and-communications-conference)

## Blogs

- [Unlocking Japan's Thriving Pharma Landscape in 2024](https://www.freyrsolutions.com/blog/unlocking-japans-thriving-pharma-landscape-in-2024)
- [The EU GCD: Ensuring Transparency and Combating Greenwashing in Cosmetics](https://www.freyrsolutions.com/blog/the-eu-gcd-ensuring-transparency-and-combating-greenwashing-in-cosmetics)
- [Embracing the EU DPP: Streamlining Compliance Through Innovative Solutions](https://www.freyrsolutions.com/blog/embracing-the-eu-dpp-streamlining-compliance-through-innovative-solutions)
- [ERAs for Pharmaceuticals in the EU: Major Regulatory Updates and Requirements](https://www.freyrsolutions.com/blog/eras-for-pharmaceuticals-in-the-eu-major-regulatory-updates-and-requirements)
- [Unlocking Efficiency: The Ultimate Guide to Electronic Regulatory Document Management](https://www.freyrsolutions.com/blog/unlocking-efficiency-the-ultimate-guide-to-electronic-regulatory-document-management)
- [Regulatory Practices: Novel Food Approval Process in Singapore](https://www.freyrsolutions.com/blog/regulatory-practices-novel-food-approval-process-in-singapore)
- [Regulatory Pathway for Food Products and Dietary Supplements in South Africa](https://www.freyrsolutions.com/blog/regulatory-pathway-for-food-products-and-dietary-supplements-in-south-africa)
- [Regulatory Labeling Requirements for Food Supplements in Italy, Spain, France, Poland, and the EU as a Whole](https://www.freyrsolutions.com/blog/regulatory-labeling-requirements-for-food-supplements-in-italy-spain-france-poland-and-the-eu-as-a-whole)