##  [Regulatory Roundup - July 29, 2024](/index%2ephp/regulatory-roundup/week-of-july-29-2024) 

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



## Top Industry News

- [FDA Guidance for Providing Over-the-Counter Monograph Submissions in Electronic Format](https://www.fda.gov/media/161822/download)
- [ANSM - European Regulations on Medical Devices and In Vitro Diagnostics: Publication of a “Consensus Statement” for the European Commission](https://ansm.sante.fr/actualites/reglements-europeens-relatifs-aux-dispositifs-medicaux-et-de-diagnostics-in-vitro-publication-dun-consensus-statement-a-destination-de-la-commission-europeenne)
- [MHRA Guidance on Good Clinical Practice (GCP) for Clinical Trials](https://www.gov.uk/guidance/clinical-trials-for-medicines-good-clinical-practice-inspections)
- [Mexico Cofepris Submits a Standard for Consultation to Guarantee the Safety and Effectiveness of Medical Devices](https://www.gob.mx/cofepris/es/articulos/cofepris-somete-a-consulta-norma-para-garantizar-la-seguridad-y-eficacia-de-dispositivos-medicos?idiom=es)
- [Deficiency Analysis in On-Site Good Manufacturing Practice (GMP) Inspections of Manufacturers for Medicinal Products and Cosmetics by NPRA](https://npra.gov.my/index.php/en/announcements/1527641-deficiency-analysis-in-on-site-good-manufacturing-practice-gmp-inspections-of-manufacturers-for-medicinal-products-and-cosmetics-by-national-pharmaceutical-regulatory-agency-npra-ministry-of-health-malaysia.html)
- [ANVISA - Find Out More: Standard Operating Procedure for Risk Classification of Pending Drug Registration Issues](https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/confira-informacoes-sobre-procedimento-operacional-padrao-para-enquadramento-de-risco-das-pendencias-de-registro-de-medicamentos)
- [FDA Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products](https://www.fda.gov/media/152503/download)
- [FDA: Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers](https://www.fda.gov/media/180206/download)
- [ANVISA Discover CMED's New Standards Monitoring Panel](https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/conheca-o-novo-painel-de-acompanhamento-de-normas-da-cmed)
- [Mexico Cofepris Approves Clinical Trial for Innovative Vaccine Against Melanoma](https://www.gob.mx/cofepris/es/articulos/cofepris-aprueba-ensayo-clinico-para-vacuna-innovadora-contra-melanoma?idiom=es)
- [MHRA - Medical Devices Given Exceptional Use Authorisations During the COVID-19 Pandemic](https://www.gov.uk/government/publications/medical-devices-given-exceptional-use-authorisations)
- [The "Food Standards (Application A1257 – Australian native bee honey – Consequential Amendments) Variation" updates the Australia New Zealand Food Standards Code by including native bee honey in relevant sections, adjusting definitions, labeling requirements, and residue limits for food](https://www.legislation.gov.au/F2024L00894/latest/text)
- [Amendment No. 229: Regulatory amendments to various standards and schedules in the Australia New Zealand Food Standards Code](https://www.foodstandards.gov.au/food-standards-code/gazette/amendment-no-229)
- [IMPORTANT – CTPA's Response to the UK REACH Consultation on ATRm](https://www.ctpa.org.uk/news/important-ctpa-response-to-the-uk-reach-consultation-on-the-atrm-7850)
- [IMPORTANT – CTPA Alerts on Non-compliant CPSRs in the UK](https://www.ctpa.org.uk/news/important-non-compliant-cpsrs-in-the-uk-7866)
- [Renew your AICIS Registration for 2024-25](https://www.industrialchemicals.gov.au/news-and-notices/its-time-renew-your-aicis-registration-2024-25)
- [AICIS-Chemical Added to the Inventory Following Issue of an Assessment Certificate (early listing)](https://www.industrialchemicals.gov.au/news-and-notices/chemical-added-inventory-following-issue-assessment-certificate-early-listing-29-july-2024)



## Upcoming Events

- [CPhI Korea 2024 (28-30 August 2024)](https://www.cphi.com/korea/)

## Blogs

- [The Evolution and Future of eCTD tools](https://www.freyrsolutions.com/blog/the-evolution-and-future-of-ectd-tools)
- [Understanding MSDS Requirements in the EU](https://www.freyrsolutions.com/blog/understanding-msds-requirements-in-the-eu)
- [Taming the Regulatory Document Chaos: How ERDMS Brings Order to the Madness](https://www.freyrsolutions.com/blog/taming-the-regulatory-document-chaos-how-erdms-brings-order-to-the-madness)