##  [Regulatory Roundup - June 17, 2024](/index%2Ephp/regulatory-roundup/week-of-june-17-2024) 

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



## Top Industry News

- [The Danish Medicines Agency (DMA) - Deadlines & CTIS: Deadlines for Clinical Trials Must be Monitored in CTIS and Regulatory Trials Must be Transferred to CTIS](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Flaegemiddelstyrelsen.dk%2Fen%2Fnews%2F2024%2Ftidsfrister-ctis-tidsfrister-for-kliniske-forsoeg-skal-overvaages-i-ctis-og-forordningsforsoeg-skal-overfoeres-til-ctis-%2F&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706648165%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=1iUUcj0abBFt9n8Pjteqy8BDM3UhYQrFqIt3nRRaKmI%3D&reserved=0)
- [EU Amends Olive Oil Marketing Standards with New Regulation Effective 2024](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Feur-lex.europa.eu%2Flegal-content%2FEN%2FTXT%2F%3Furi%3DCELEX%253A32024R1401%26qid%3D1716428851867&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706659668%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=gqUwXIwLhio3zRmlzJfjYIxNSApitKoZBl97OgnGFKI%3D&reserved=0)
- [MHRA Guidance on Machine Learning Medical Devices: Transparency Principles](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.gov.uk%2Fgovernment%2Fpublications%2Fmachine-learning-medical-devices-transparency-principles&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706664199%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=n9Qu3Vgh3Ya76ysiy7nCa9ElYR2DgDXemdGEBYVgjU4%3D&reserved=0)
- [MFDS Proposes Amendments to Food Code in South Korea](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.mfds.go.kr%2Fbrd%2Fm_209%2Fview.do%3Fseq%3D43936%26srchFr%3D%26srchTo%3D%26srchWord%3D%26srchTp%3D%26itm_seq_1%3D0%26itm_seq_2%3D0%26multi_itm_seq%3D0%26company_cd%3D%26company_nm%3D%26page%3D1&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706668454%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=NNk8wIxNJ%2FpY7APQV6nXE4V4ZUFAg468NERjkbxjBxg%3D&reserved=0)
- [Swissmedic has Simplified the Requirements for the Re-Authorisation of Medicinal Products](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.swissmedic.ch%2Fswissmedic%2Fde%2Fhome%2Fhumanarzneimittel%2Fauthorisations%2Finformationen%2Fvereinfachung-anforderungen-erneute-zl.html&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706672695%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=TKeDatqP5NlnAAWOyDCsUUTNoZqUTvqOC8tufyX6USs%3D&reserved=0)
- [Deodorant Efficacy of Xylityl Sesquicaprylate Vehiculated into Roll-on and Stick Prototype Formulations](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.mdpi.com%2F2079-9284%2F11%2F3%2F88&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706676965%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=2trlh8jwDV5WbcJSKo%2BaCiwo1oKuAT8dxOK65zBajU0%3D&reserved=0)
- [SCCS - Request for an Addendum to SCCS/1658/23 to cover children’s exposure to Hexyl Salicylate (hexyl 2-hydroxybenzoate) from cosmetic products](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fhealth.ec.europa.eu%2Flatest-updates%2Fsccs-request-addendum-sccs165823-cover-childrens-exposure-hexyl-salicylate-hexyl-2-hydroxybenzoate-2024-05-31_en&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706681028%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=dVgIpDhvKTxG6t3GAi2%2Bh0rPeo6qxb53gE3LF5BlCQQ%3D&reserved=0)
- [The Ministry of Health and Welfare has amended the Restriction Table on the Use of Cosmetic Ingredients to strengthen the safety of cosmetics and protect the health and safety of consumers](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov.tw%2FTC%2FnewsContent.aspx%3Fcid%3D3%26id%3D30575&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706685253%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=mlakN%2BLi%2BlNnNdBVhRcNoEB7aBpWKTM1Q4IM09NB0LA%3D&reserved=0)
- [EFSA Assessment of Pyridine, Pyrrole, and Quinoline Derivatives (FGE77)](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.efsa.europa.eu%2Fen%2Fefsajournal%2Fpub%2F936&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706689340%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=kNB6Hcj39YEUwFd9vg9nRGpUaNgbjoMTIqzgROzb8zs%3D&reserved=0)
- [PMDA - Notification System for Clinical Trial Plans for Medical Devices (Machinery, Instruments, Etc.)](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.pmda.go.jp%2Freview-services%2Ftrials%2F0003.html&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706693441%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=9W9X%2BzgcFxJw7BEHrnDY9FezaYbz%2BSoSjbin2newrYE%3D&reserved=0)
- [Swissmedic - New Developments in Goods Declaration for the Export of Medicinal Products (Including Clinical Trials) and Narcotics at the Federal Office for Customs and Border Security (Bazg)](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.swissmedic.ch%2Fswissmedic%2Fde%2Fhome%2Fnews%2Fmitteilungen%2Fneuerungen-warenanmeldung-ausfuhr-am.html&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706697511%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=RUbhl7k2yTCpNMHBqZ2iTun4BBqaU5OBlPqpYi8erbU%3D&reserved=0)
- [MHRA Guidance on Software and Artificial Intelligence (AI) as a Medical Device](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.gov.uk%2Fgovernment%2Fpublications%2Fsoftware-and-artificial-intelligence-ai-as-a-medical-device&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706701607%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=MZDcfl5LgBPYSuiLZY1mpaKbgQQfvG2%2FKrqQFJNuQlQ%3D&reserved=0)
- [PMDA - Notification System for Clinical Trial Plans for Regenerative Medicine Products (Processed Cells, Etc.)](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.pmda.go.jp%2Freview-services%2Ftrials%2F0006.html&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706705682%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=yM2Loqv%2Fe4NJEFf5xYBYriJFe3ordeQTWLBzM%2BMf%2BeE%3D&reserved=0)
- [MHRA Performance Data for Assessment of Clinical Trials and Established Medicines](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.gov.uk%2Fgovernment%2Fpublications%2Fmhra-performance-data-for-assessment-of-clinical-trials-and-established-medicines&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706709763%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=aMi8gVAmSaqxaBDmwKOE8VDz%2BcJYjXBeepjX6tgKwLo%3D&reserved=0)
- [EMA - Two New Advice Pilots to Improve Clinical Trials in Europe](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fnews%2Ftwo-new-advice-pilots-improve-clinical-trials-europe&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706713967%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=vaO%2FBvvZH6nk%2BqlSxnKef9dr289qYCJUERkwc7VOoAk%3D&reserved=0)
- [FDA Draft Guidance on Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F159414%2Fdownload&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706718109%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=%2Bp4NGMHx%2BSSOVV3D52aJELDl2Jk0h0sK38KDI8hxAMg%3D&reserved=0)
- [ANVISA - Webinar Presents Public Consultation in the area of ​​Pharmacopoeia](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.gov.br%2Fanvisa%2Fpt-br%2Fassuntos%2Fnoticias-anvisa%2F2024%2Fwebinar-apresenta-consulta-publica-da-area-da-farmacopeia&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706722097%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=poz6g4o%2BT0Yn%2FC1PZ73SMRb5DFN2Nbpnps7HeAAuoP0%3D&reserved=0)

## Mergers & Acquisitions

- [Ono Announces Results of Tender Offer to Acquire Deciphera Pharmaceuticals and Completion of Acquisition of Deciphera](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ono-pharma.com%2Fen%2Fnews%2F20240611.html&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706726297%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=EypOom9s349xjDNnj%2Fj4M6AFUISqP0dJns8TDmXJHA0%3D&reserved=0)



## Upcoming Events

- [11th Pharma Packaging & Labeling Innovation Forum](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.brainlinx.com%2Fconference%2F11th-PHARMA-PACKAGING-2024%2Findex.php&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706734358%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=jDfwRsisAZHJaGaciiXh6hYe4ZubKADaho5Uy5gQVMk%3D&reserved=0)
- [8th Annual Medical Device Regulatory and Quality Summit 2024](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fmeddeviceregulatorysummit.com%2F&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706738440%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=kqLoT1rQ9heef0GYE1ddWC%2FH9NaryRyqtd0K3gEsoTg%3D&reserved=0)

## Blogs

- [The Critical Role of Proper Deviation Management in Pharma Compliance](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.freyrsolutions.com%2Fblog%2Fthe-critical-role-of-proper-deviation-management-in-pharma-compliance&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706742467%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=rm0%2FOgEdxcBojK5pPDQlp5NPyLO470NuF4aDe%2Fi8bKE%3D&reserved=0)
- [Mastering GMP/GDP Audits: Conducting In-depth Investigations for Compliance](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.freyrsolutions.com%2Fblog%2Fmastering-gmpgdp-audits-conducting-in-depth-investigations-for-compliance&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706746536%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=bEBYLm%2FL6J9ptWlfFrZMAjYVPK0zE1u17DOInuY9YG0%3D&reserved=0)
- [Finding the Right Mix of Automated and Manual Proofreading for Packaging Artwork](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.freyrsolutions.com%2Fblog%2Ffinding-the-right-mix-of-automated-and-manual-proofreading-for-packaging-artwork&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706750636%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=cjk7gGEPgMyEYBfaiKgoPIYdswfE44DZpEqoDfmJH5c%3D&reserved=0)
- [Steps followed by regulatory authorities to navigate PMS and enforcement effectively](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.freyrsolutions.com%2Fblog%2Fsteps-followed-by-regulatory-authorities-to-navigate-pms-and-enforcement-effectively&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706754703%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=VWGQMNzPyid3SAVR4rM4%2BLOMYw4zjmfP36L3NMDffNE%3D&reserved=0)
- [SPL-SPM: What are the differences?](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.freyrsolutions.com%2Fblog%2Fspl-spm-what-are-the-differences&data=05%7C02%7Cdinesh.m%40FreyrSolutions.com%7C52f202e0df0644db4eed08dc8ec0f911%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638542206706758745%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=UtjDyERPNCYDcMcqgb7DR6Hckp7V5H6fdwZkmGNCZ3s%3D&reserved=0)