## [Regulatory Roundup - June 10, 2024](/index%2Ephp/regulatory-roundup/week-of-june-10-2024) [Back to Regulatory Roundup Archive](/regulatory-roundup) ## Top Industry News - [Swissmedic - New Regulatory Law Applies from 1 November 2024](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.swissmedic.ch%2Fswissmedic%2Fde%2Fhome%2Fnews%2Fmitteilungen%2Fneues-verordnungsrecht-ab-1-nov-2024.html&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070129549%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=xObb4SoB2RwscJcbIl9GC1J0pHKO7zQDbvcxC9qA908%3D&reserved=0) - [Malaysia MDA - Implementation of the One License For Each Establishment Role 1 July 2024](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fportal.mda.gov.my%2Findex.php%2Fannouncement%2F1415-pelaksanaan-dasar-satu-lesen-untuk-setiap-peranan-establismen-mulai-1-julai-2024&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070145338%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=s0HvDo5x%2BpCK4iothMw24s4NPe7XkPTf%2FQgvA%2Bo9llg%3D&reserved=0) - [Partial Revision of Food Standards and Specifications - Ministry of Food and Drug Safety Notice No. 2024-22](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.mfds.go.kr%2Fbrd%2Fm_207%2Fview.do%3Fseq%3D14975%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%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070154213%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=vqN0rkY0IQxBhx%2BjMwgnOECFwbZTv3k9lbjx4zR1ihc%3D&reserved=0) - [ANVISA Changes the Rule that Deals With the Post-Registration of Biological Products](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.gov.br%2Fanvisa%2Fpt-br%2Fassuntos%2Fnoticias-anvisa%2F2024%2Fanvisa-altera-norma-que-trata-do-pos-registro-de-produtos-biologicos&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070160039%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=GPwcR3I8tGIoLu7JgoGP08hcRZKc4mBYjUrYSFXecjo%3D&reserved=0) - [TGA - Proactive Monitoring of Highest-Risk Medical Device Clinical Trials](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.tga.gov.au%2Fnews%2Fnews%2Fproactive-monitoring-highest-risk-medical-device-clinical-trials&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070165713%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=WiM9LAhHU3skzqo%2BSRxyLVGOHWCDcsCp7XJQkYLF5oE%3D&reserved=0) - [The Scientific Committee on Consumer Safety (SCCS) has Released a Draft Opinion on a New Coating for Titanium Dioxide](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fhealth.ec.europa.eu%2Fdocument%2Fdownload%2Fdb310eb8-f2ee-47a6-b47a-df52c692f97c_en%3Ffilename%3Dsccs_o_289.pdf&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070171266%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=Ts9OVZlQ7x%2BiZGoDldgtQjlTAC2kLJkN%2BHtCwoQPRoY%3D&reserved=0) - [Swissmedic - Adaptation of the Guideline Changes and Authorisation Extensions HAM](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.swissmedic.ch%2Fswissmedic%2Fde%2Fhome%2Fhumanarzneimittel%2Fauthorisations%2Finformationen%2Fanpassung-wl-ae-zlerweiterung-ham.html&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070176741%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=eZWm8ENhGMWyw%2BYcI7%2FQv56CPiDOmzLuHoaf21hFCsM%3D&reserved=0) - [EPA Proposes New Regulations to Safeguard Against Hazardous Chemical N-Methylpyrrolidone (NMP)](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.epa.gov%2Fnewsreleases%2Fepa-proposes-requirements-protect-workers-and-consumers-exposure-toxic-solvent-n&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070182295%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=41EsB2y1h7H%2BQ%2F%2FdFrSB6cqPz%2BP%2BMGclYPR1ZW%2BdWJs%3D&reserved=0) - [PMDA Updated "Submission of Documents to the Pharmaceutical Affairs Council (Medical Drugs)"](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.pmda.go.jp%2Freview-services%2Fdrug-reviews%2Fprocedures%2F0020.html&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070187692%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=eD%2FPrGOs3xnuuZSvFMAueJQ5ONqGHCiWvH27myWC7YM%3D&reserved=0) - [WTO- Requirements, Sampling and Test Methods for Nixtamalized Maize Products Prepared from the Grains of Common Maize (Zea mays L.) Intended for Human Consumption](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fepingalert.org%2Fen%2FSearch%3FcountryIds%3DC404%26distributionDateFrom%3D2024-05-21%26viewData%3D%2520G%252FTBT%252FN%252FKEN%252F162&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070193027%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=ubuuVR9eOvwmARllSLJqIbMamfRSQXChblg03WnLaY4%3D&reserved=0) - [FDA Draft Guidance on Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center for Biologics Evaluation and Research Submissions](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F179136%2Fdownload&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070198501%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=aAG9DCaAjQ31CQyJUvehjKNLyFKIPTpj%2FSlCx9bZmaI%3D&reserved=0) - [Health Canada's PMRA is Seeking Public Comments on Proposed Maximum Residue Limits (MRLs) for the Pesticide Picarbutrazox by July 30, 2024](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.canada.ca%2Fen%2Fhealth-canada%2Fservices%2Fconsumer-product-safety%2Fpesticides-pest-management%2Fpublic%2Fconsultations%2Fproposed-maximum-residue-limit%2F2024%2Fpicarbutrazox.html&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070203740%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=RafBZzbRZ24a%2BJfPa20Hukyrup%2BLKBIOPPpFF4ZTCAY%3D&reserved=0) - [PMDA Published Guidelines for Filling out Electronic Package Inserts for Regenerative Medicine Products](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.pmda.go.jp%2Fsafety%2Fconsultation-for-mah%2F0002.html&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070209184%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=q5A7gZO0mMop1fXcF36Uu0tDUDeVHbjKolDVppL%2F%2BzE%3D&reserved=0) - [FDA Draft Guidance on Processes and Practices Applicable to Bioresearch Monitoring Inspections](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2Fregulatory-information%2Fsearch-fda-guidance-documents%2Fprocesses-and-practices-applicable-bioresearch-monitoring-inspections&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070214428%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=DTpmIztPVMM%2BlSrbw8Ckbe465OUR%2B6RuplbEDb4voL4%3D&reserved=0) - [Taiwan FDA -Restricted List of Ingredients for Cosmetic Sunscreens](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov.tw%2FTC%2FnewsContent.aspx%3Fcid%3D3%26id%3D30576&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070219848%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=70FYemkjJHzEm02IntTzv910cJmFHKmDZKlNoAXcl2k%3D&reserved=0) - [PMDA Published Guidelines for Promoting Optimal use of Regenerative Medicine Products](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.pmda.go.jp%2Freview-services%2Fdrug-reviews%2Freview-information%2Fctp%2F0011.html&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070225108%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=hWsYQa%2F8jUXRlsl7uTwanEtaXLGVpD3Ihrw4E9kj0WY%3D&reserved=0) ## Mergers & Acquisitions - [Acquisition of Fusion Pharmaceuticals Completed](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.astrazeneca.com%2Fmedia-centre%2Fpress-releases%2F2024%2Facquisition-of-fusion-completed.html&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070230448%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=ghx5GVJGYek1lVJXVLR3tvgglTOkerk7Cq5gTBKcTrw%3D&reserved=0) - [Apotex Completes Acquisition of Searchlight Pharma](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.apotex.com%2Fglobal%2Fabout-us%2Fpress-center%2F2024%2F06%2F03%2Fapotex-completes-acquisition-of-searchlight-a-leading-canadian-based-specialty-innovative-branded-pharmaceutical-company&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070235820%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=wYUW%2F0KRX21Jlz66JbdeVfWt3O6xfx2bMUogrbbFSg8%3D&reserved=0) ## Upcoming Events - [MedtecLIVE 2024](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.medteclive.com%2Fen&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070251818%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=aa2zGMveomlZlAPudDm1EeheczwmSqUqMZs680tZJFY%3D&reserved=0) - [Global Pharmaceutical Regulatory Affairs Summit 2024](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Finformaconnect.com%2Fglobal-pharmaceutical-regulatory-affairs%2F&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070256986%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=wyWz1hMLDXwEB%2F4rCg8Wu9BOlNTzg5NsYVfOB0v%2FviI%3D&reserved=0) ## Blog Posts - [Streamlining Pharma Labeling Compliance: The Role of Label Templates](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.freyrsolutions.com%2Fblog%2Fstreamlining-pharma-labeling-compliance-the-role-of-label-templates&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070262187%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=YzCIP0ZJw5ohfYyBSOcRxIR62S6s5s1pZOmM89bD%2BM8%3D&reserved=0) - [Supporting Labeling Compliance with Searchable Databases](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.freyrsolutions.com%2Fblog%2Fsupporting-labeling-compliance-with-searchable-databases&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070267430%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=mRG6x65c3I7jV6e38YuPaLYEBT4N95MRgorL7KPn0AY%3D&reserved=0) - [Demystifying Sunscreen Product Labeling in the EU](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.freyrsolutions.com%2Fblog%2Fdemystifying-sunscreen-product-labeling-in-the-eu&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070272677%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=EtOTqWveI5N8VjfysiIVcTq96gavaHAI%2Bz2p%2Bp1JdDI%3D&reserved=0) - [Cosmetic Regulatory Landscape in the UK – An Overview](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.freyrsolutions.com%2Fblog%2Fcosmetic-regulatory-landscape-in-the-uk-an-overview&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C590b02e5161a446adc4208dc894aeb39%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638536202070277926%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=g%2BD%2FX0A9DRKVi1Xg7hZdDx13JECj1U%2F81Zdcaef3YkM%3D&reserved=0)