##  [Regulatory Roundup - July 01, 2024](/index%2Ephp/regulatory-roundup/week-of-july-01-2024) 

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



## Top Industry News

- [FSANZ-Approval Report – Application A1283 2′-FL from GM Corynebacterium Glutamicum in Infant Formula Products](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.foodstandards.gov.au%2Ffood-standards-code%2Fapplications%2Fa1283-2-fl-gm-corynebacterium-glutamicum-infant-form&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601405655%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=Ui07qG08cYfho%2Bpps2G1U3J1H8gyf%2F2wPdkIUfj2W%2FE%3D&reserved=0)
- [NPRA - Registration Application Submitted via Facilitated Registration Pathway (FRP) - FAQs](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fnpra.gov.my%2Findex.php%2Fen%2Fcomponent%2Fcontent%2Farticle%2F453-english%2Fannouncement-main%2Fannouncement-2024%2F1527630-registration-application-submitted-via-facilitated-registration-pathway-frp-faq.html%3FItemid%3D1391&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601421549%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=WVaWXSDqm8cSuXdfpaZPr4PeTC8IOebS6Hjt3ZNLG4U%3D&reserved=0)
- [WHO- Safety Evaluation of Certain Food Additives](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Firis.who.int%2Fhandle%2F10665%2F377542&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601433607%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=pCMgoQ%2FmMd0kxgIlvqJ8dtfKO2yjQkCezgFjBc7F8aM%3D&reserved=0)
- [ANVISA Announces Startup Projects Selected to Receive Regulatory Guidance on Drug Innovation](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.gov.br%2Fanvisa%2Fpt-br%2Fassuntos%2Fnoticias-anvisa%2F2024%2Fanvisa-divulga-projetos-de-startups-selecionados-para-receber-orientacao-regulatoria-na-inovacao-de-medicamentos&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601443282%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=X8gLEEGvN4NjOBpkHHxwFSgUgtq49aQr9fNRD7py1pE%3D&reserved=0)
- [Health Canada's Marketing Authorization allows for the voluntary addition of vitamin D to yogurt and kefir to address low Vitamin D levels in Canadians and support bone health](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fgazette.gc.ca%2Frp-pr%2Fp2%2F2024%2F2024-06-05%2Fhtml%2Findex-eng.html&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601452423%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=DZsAuq4Av%2F3Qf2RBR4MuxFr%2BJOwkTlXojo%2FWP%2FJKmeY%3D&reserved=0)
- [MCNZ Consultation - Expedited pathway for registration in the Provisional Vocational scope of practice](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.mcnz.org.nz%2Fabout-us%2Fnews-and-updates%2Fconsultation-expedited-pathway-for-registration-in-the-provisional-vocational-scope-of-practice%2F&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601461081%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=lkA7vqN6d47WNkLvOFbVuuIeBhDGYl9tu2WWNPHc1vw%3D&reserved=0)
- [FDA Guidance on Laboratory Developed Tests: Small Entity Compliance](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F179543%2Fdownload&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601467683%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=FTRzgD0jaV4l99OB4%2BCw59FbsMVIefrRKxm3FewsGME%3D&reserved=0)
- [The first report of the HoA working group 'Food Supplements' highlights the need for harmonization and regulation of 'other substances' in food supplements](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.bvl.bund.de%2FSharedDocs%2FDownloads%2F01_Lebensmittel%2FInternationales%2FReport_HoA_WG_FS-de.html%3Fnn%3D12429764&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601474001%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=N3uO%2B4yrcYNg9xCdrMIe0sKjYw61nWXfKp58ZWioxnU%3D&reserved=0)
- [EMA Recommends Non-Renewal of Authorisation of Duchenne Muscular Dystrophy Medicine Translarna](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fnews%2Fema-recommends-non-renewal-authorisation-duchenne-muscular-dystrophy-medicine-translarna-0&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601480181%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=RNG7e59lIhlhwY%2FpL9DIi%2F5Lnp%2FwtOusp%2BagbWvEga4%3D&reserved=0)
- [GCC - New Cosmetic Technical Regulations Available](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.sfda.gov.sa%2Findex.php%2Far%2FAllCosmeticList&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601486175%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=Zj%2FXtwOsa6gde3O3hGNRTZVpElWcmW2rqUH139gN2hk%3D&reserved=0)
- [FDA Draft Guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F179593%2Fdownload&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601491974%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=3YizE%2B8DUKX4eAkfDtjir3%2B4eLTi11kKekGP9CIEpGU%3D&reserved=0)
- [The European Commission (EC) recalled Loreal hair conditioner because the product contains 2-(4-tert-butylbenzyl) propionaldehyde (BMHCA), which is prohibited in cosmetic products](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fec.europa.eu%2Fsafety-gate-alerts%2Fscreen%2FwebReport%2FalertDetail%2F10012304&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601498493%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=%2B4sWF%2BIktbRHYAGNMFllLXrSfUDvhQHEHRJvoVyUdq0%3D&reserved=0)
- [FDA Draft Guidance on Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F179545%2Fdownload&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601504786%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=uocaJG4JLpfVfez%2FtBqmcpL5Gz%2FzzYFT9ON8EUX%2BrK0%3D&reserved=0)
- [AICIS-Chemicals included in the Inventory five years post issuance of assessment certificate](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.industrialchemicals.gov.au%2Fnews-and-notices%2Fchemicals-added-inventory-5-years-after-issue-assessment-certificate-26-june-2024&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601510794%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=4IcwVYs7tP%2FmJaVYMD9gjQ6LzTwQ9vjwBfm9GqGoCTw%3D&reserved=0)
- [ECHA adds one hazardous chemical to the Candidate List](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fecha.europa.eu%2F-%2Fecha-adds-one-hazardous-chemical-to-the-candidate-list&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601516929%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=ugBfeWSU%2FzjaZb7X%2FsWmlVKrxb2bVCwR3RZB%2B2BSbKM%3D&reserved=0)
- [ANVISA Quarterly Update of Medical Device Economic Monitoring Dashboards Available](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.gov.br%2Fanvisa%2Fpt-br%2Fassuntos%2Fnoticias-anvisa%2F2024%2Fdisponivel-atualizacao-trimestral-dos-paineis-de-monitoramento-economico-de-dispositivos-medicos&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601523731%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=mbJ8WJTx2o6MTFQu69LN8EOYqm8VN7GNt40L4GcVWX0%3D&reserved=0)
- [CTPA Relaunches its Member-only “Cosmetics Masterclass”](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ctpa.org.uk%2Fnews%2Fctpa-relaunches-its-member-only-cosmetics-masterclass-7784&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601532648%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=%2BnIXsohk3CWa3SedshCD%2Fl6bqjl8u80Moj6XXDDGlkE%3D&reserved=0)
- [EMA Recommends Revoking Conditional Marketing Authorisation for Ocaliva](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fnews%2Fema-recommends-revoking-conditional-marketing-authorisation-ocaliva&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601540654%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=QmhTI9vNT61I%2FxY8z2WdZplY1vN2fpcnMm7e9qP%2BBGA%3D&reserved=0)
- [ANVISA Publishes Studies on Agile Regulation and Experimental Regulation](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.gov.br%2Fanvisa%2Fpt-br%2Fassuntos%2Fnoticias-anvisa%2F2024%2Fmelhoria-da-qualidade-regulatoria-anvisa-publica-estudos-sobre-regulacao-agil-e-regulacao-experimental&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601547557%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=QC7%2BZLE3Z2oEv%2BiOR%2F9sYTQ6JE5ySVCgn6ESbgvS5Nk%3D&reserved=0)

## Mergers & Acquisitions

- [Quest Diagnostics to Acquire Select Lab Assets from Allina Health](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fnewsroom.questdiagnostics.com%2F2024-06-26-Quest-Diagnostics-to-Acquire-Select-Lab-Assets-from-Allina-Health&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601554443%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=mTkEqzF3SGCz%2FN2bWjAmhfk7cdlWnV6YOd%2BegDTnoy0%3D&reserved=0)
- [Sun Pharma Completes Taro Merger](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fsunpharma.com%2Fwp-content%2Fuploads%2F2024%2F06%2FPress-Release-Sun-Pharma-Completes-Taro-Merger.pdf&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601561311%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=V3lzXP1xNvNNw91yAnaZtLD%2BqB2fvGGOjeZTVoFj9jY%3D&reserved=0)
- [AbbVie Acquires Celsius Therapeutics](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fnews.abbvie.com%2F2024-06-27-AbbVie-Acquires-Celsius-Therapeutics%3F_gl%3D1%2Am6o3o4%2A_ga%2AMTkyMDgwODExMS4xNzE5ODI0NzU3%2A_ga_5LEXD56YGK%2AMTcxOTgyNDc1Ny4xLjEuMTcxOTgyNDgyNy4wLjAuMA..%26_ga%3D2.103833352.90981334.1719824758-1920808111.1719824757&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601568559%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=ftibBlBA9qUkI5GPM1N%2BiNjRmgqT8LZg7Hdg1K0RSs4%3D&reserved=0)



## Upcoming Events

- [COSMOPROF  LAS Vegas](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fcosmoprofnorthamerica.com%2Flas-vegas%2F%3F_gl%3D1%2A1qf303j%2A_up%2AMQ..%2Alocal_ga%2AMTUzNDE2MDA5Ny4xNzAzODM0NDM0%2Alocal_ga_397WVCL76P%2AMTcwMzgzNDQzMi4xLjAuMTcwMzgzNDQzMi4wLjAuMA..&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601601066%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=1LFned0hX44jCA98YZxmG3CyiMbEuw2khbI8t6DFgy0%3D&reserved=0)
- [Wellness Food Japan](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwfjapan.com%2Fen%2F&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601607439%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=5YKiqQoUMZtT%2B%2Fjyz4oTpwivJWs4rqZaJGJexuZ6a7k%3D&reserved=0)
- [IFT](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.iftevent.org%2F&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7Cfcef4d7e48c443a011ad08dc99c23443%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638554306601613320%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=lvHZFjbk4eKh3oGa3TUee4i39zlXhjPWiSEphKcfSqs%3D&reserved=0)