##  [Regulatory Roundup - July 08, 2024](/index%2Ephp/regulatory-roundup/week-of-july-08-2024) 

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



## Top Industry News

- [Danish Medicines Agency New Regulations on Stockpiling of Critical Medicines Effective on July 1 2024](https://laegemiddelstyrelsen.dk/en/news/2024/new-regulations-on-stockpiling-of-critical-medicines-effective-on-july-1-2024/)
- [MHRA Guidance on UK Approved Bodies Listed Under Medical Devices Regulations 2002](https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies)
- [FDA Prohibits the Use of Brominated Vegetable Oil (BVO) in Food](https://www.fda.gov/food/hfp-constituent-updates/fda-revokes-regulation-allowing-use-brominated-vegetable-oil-bvo-food?utm_medium=email&utm_source=govdelivery)
- [IMDRF Publishes Guiding Principles on the Good Machine Learning (ML) Practice for Medical Device Development](https://www.imdrf.org/consultations/good-machine-learning-practice-medical-device-development-guiding-principles)
- [Swissmedic - Adaptation of the forms for new authorisation of human medicinal products or changes and extensions of authorisation HAM](https://www.swissmedic.ch/swissmedic/de/home/humanarzneimittel/authorisations/informationen/aenderung-anpassung-fo-neuzulassung-zulassungserweiterung.html)
- [The Swedish Food Agency provides guidance on meeting food information requirements in e-commerce, focusing on mandatory information, supporting website material, and additional labeling for dietary supplements and confectionery](https://kontrollwiki.livsmedelsverket.se/artikel/60/kontrollsystemet)
- [MDA Malaysia: MeDC @St3.0 Project Development Timeline - License & Registration Modules](https://portal.mda.gov.my/index.php/announcement/1430-medc-st3-0-project-development-timeline)
- [ANVISA Participate in the Targeted Consultation on Good Pharmacopoeial Practices](https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/participe-da-consulta-dirigida-sobre-boas-praticas-farmacopeicas)
- [Regulations on Changes in Regulations on Plant Protection Products](https://lovdata.no/register/lovtidend)
- [Cosmetic Ingredients Added to the GB MCL (Contains 14th and 15th EU ATP to CLP)](https://www.hse.gov.uk/chemical-classification/assets/docs/cwbsd-aapu-0675.pdf)
- [ANVISA Reestablishment of the Documentary Repository of InVitro Diagnostic Medical Devices](https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/reestabelecimento-do-repositorio-documental-de-dispositivos-medicos-para-diagnostico-in-vitro)
- [SCCS - Final Opinion on the Safety of Silver (CAS/EC No. 7440-22-4/231-131-3) in Cosmetic Products](https://health.ec.europa.eu/latest-updates/sccs-final-opinion-safety-silver-casec-no-7440-22-4231-131-3-used-cosmetic-products-2024-07-03_en)
- [FDA Draft Guidance on M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines](https://www.regulations.gov/document/FDA-2024-D-2754-0001)
- [SCCS Published- Summary of the 2023 Annual Report on Serious Adverse Reactions and Events for Tissues and Cells (2022 Data)](https://health.ec.europa.eu/latest-updates/summary-2023-2022-data-annual-reporting-serious-adverse-reactions-and-events-tissues-and-cells-2024-06-28_en)
- [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)
- [WTO was notified about an addendum to the Supplemental Technical Regulations for DAO 22-06, Series of 2022 on the Mandatory Product Certification of Vaporized Nicotine and Non-Nicotine Products. It is applicable to vapour products and their refills, HTP systems, consumables and devices](https://members.wto.org/crnattachments/2024/TBT/PHL/final_measure/24_03857_00_e.pdf)
- [Hong Kong Government Tightens Tobacco Regulations, Considers E-Cigarette Possession Ban](https://www.jetro.go.jp/biznews/2024/06/ef0f8bba8c7dc5e0.html)
- [MHRA - Implementation of Medical Devices Future Regime](https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices)

## Mergers & Acquisitions

- [Biogen Completes Acquisition of Human Immunology Biosciences](https://investors.biogen.com/news-releases/news-release-details/biogen-completes-acquisition-human-immunology-biosciences)
- [Pentixapharm Acquires Target Discovery Business of Glycotope](https://www.pentixapharm.com/news/pentixapharm-acquires-target-discovery-business-of-glycotope)



## Upcoming Events

- [Biologics Manufacturing Korea 2024](https://www.imapac.com/events/biologics-manufacturing-korea-2026)
- [11th Annual American Medical Device Summit](https://amdsummit.com/)
- [HKTDC Food Expo PRO 2024](https://www.hktdc.com/event/foodexpopro/en)

## Blogs

- [Strengthening Patient Safety: Uniting 3 Pillars of Medical and Scientific Communications for Effective Care](https://www.freyrsolutions.com/blog/strengthening-patient-safety-uniting-3-pillars-of-medical-and-scientific-communications-for-effective-care)
- [Regulatory Requirements for Tobacco Products in Mexico: A Comprehensive Guide](https://www.freyrsolutions.com/blog/regulatory-requirements-for-tobacco-products-in-mexico-a-comprehensive-guide)
- [An Overview of South Korea’s SaMD Approval Guidelines](https://www.freyrsolutions.com/blog/an-overview-of-south-koreas-samd-approval-guidelines)
- [Understanding the Cosmetic Regulatory Framework in South Korea: Essential Guidelines for Market Entry](https://www.freyrsolutions.com/blog/understanding-the-cosmetic-regulatory-framework-in-south-korea-essential-guidelines-for-market-entry)
- [Understanding Regional Regulations of ASEAN and their Impact on Cosmetic Products](https://www.freyrsolutions.com/blog/understanding-regional-regulations-of-asean-and-their-impact-on-cosmetic-products)
- [Ensuring Cosmetic Labeling Compliance in the EU Market: Mandatory Information and Best Practices Ensuring Cosmetic Labeling Compliance in the EU Market: Mandatory Information and Best Practices](https://www.freyrsolutions.com/blog/ensuring-cosmetic-labeling-compliance-in-the-eu-market-mandatory-information-and-best-practices)
- [Ensuring Compliance with the UK Safety and Testing Standards: Key Considerations for Manufacturers Ensuring Compliance with the UK Safety and Testing Standards: Key Considerations for Manufacturers](https://www.freyrsolutions.com/blog/ensuring-compliance-with-the-uk-safety-and-testing-standards-key-considerations-for-manufacturers)