##  [Regulatory Roundup - June 25, 2024](/index%2Ephp/regulatory-roundup/week-of-june-25-2024) 

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



## Top Industry News

- [EU Member States Enforce Product Recalls for Label Non-Compliance](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Filfattoalimentare.it%2Fnutella-gelato-scatta-gia-il-primo-richiamo-segnalate-anche-cosce-di-rana.html&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301174702%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=g%2FPzmRa%2BIzHdRBPWMPpc3nhcrSZ9jV7aFZg%2BXTe35WQ%3D&reserved=0)
- [Faster Access to Clinical Trial Information in Europe](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fnews%2Ffaster-access-clinical-trial-information-europe&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301188602%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=I8hgvK38LSUCOn06TcP0QmmJi3wAcYQl9IJjFhAJwKo%3D&reserved=0)
- [TGA Medical Device Regulation Changes](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.tga.gov.au%2Fnews%2Fnews%2Fmedical-device-regulation-changes&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301199227%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=GTEoKzF65I7sTxj6QQdVgc241p9QvTK6dlKNdwT%2FsYU%3D&reserved=0)
- [MFDS Proposes Amendments to Food Code in South Korea](WTO:New%20Packaging%20Recycling%20Label%20Regulation%20Drafted%20for%20UK%20Producers)
- [FDA Guidance for Goal Date Decisions Under GDUFA Generic Drugs](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F162018%2Fdownload&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301211329%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=alqbHpz6Sug5zElTvb6nfnMpOkC%2BeUdJrcfrcS1mBLk%3D&reserved=0)
- [HSA Organized a webinar on Next Generation Medical Devices (NextGen MD) Initiative](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hsa.gov.sg%2Fannouncements%2Fregulatory-updates%2Fwebinar-on-nextgen-md-initiative&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301222682%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=O%2FKusTdU65fHhqhcKZucfJUxQwQT3o%2B8QnZ9IUFtECo%3D&reserved=0)
- [FDA Draft Guidance on Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F86328%2Fdownload&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301232168%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=wMJXmJyaT2oV7Ez3NVr3O1xoT3vM20Hra%2FE6eHUN1Jk%3D&reserved=0)
- [PMDA Published Risk Communication Guidance Based on Systematic Risk Assessment Methods for Nitrosamines Contained in Pharmaceuticals](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.pmda.go.jp%2Fsafety%2Finfo-services%2Fdrugs%2F0371.html&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301239252%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=ts%2BWOj9gRoaotYOHBDENJlYj%2B9Q9vrXxNDZCgg12MPQ%3D&reserved=0)
- [EFSA Approves New Vitamin D Source from UV-Exposed Mushroom Powder](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fefsa.onlinelibrary.wiley.com%2Fdoi%2Ffull%2F10.2903%2Fj.efsa.2024.8817&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301245879%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=f2gX3qSAjuSWOn%2FD4YEGLD23uHxpwZAcGhHT45E9B%2B4%3D&reserved=0)
- [PMDA Published New Guidelines and Documents Related to Clinical and Non-Clinical Evaluation of Vaccines](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.pmda.go.jp%2Freview-services%2Fdrug-reviews%2Fabout-reviews%2Fp-drugs%2F0032.html&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301252135%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=oWaRud1AYgj%2BdOX1Hma7XZhP8uhOuCMFguledSyN7fw%3D&reserved=0)
- [SCCS Meeting Highlights: BHT, Acid Yellow 3, and CI 77266 in Cosmetics](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fhealth.ec.europa.eu%2Fdocument%2Fdownload%2F698a610e-3c35-4bc2-91fb-90f2ca98e431_en%3Ffilename%3Dsccs2022_miwg_050.pdf&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301258251%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=4IJEJTNqriQ1KAj6Me5E%2BqeQ732GZWqqz6g78Z%2BjkBs%3D&reserved=0)
- [FDA Draft Guidance on Considerations in Demonstrating Interchangeability With a Reference Product](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F179456%2Fdownload&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301264316%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=FXthBZeB%2F3OM9UdlVDQkPclVI1v6G4IJZ6CGl2lXsSk%3D&reserved=0)
- [New Compostable Product Labeling Standards Announced in Washington State](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fecology.wa.gov%2Fblog%2Fjune-2024%2Forganics-management-in-washington-changes-to-compostable-product-labeling&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301270070%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=ZrXBiyuvOeb1c7JbUnz2Gk%2BLj1AlTXlq3FDpKY8Q6p8%3D&reserved=0)
- [Canada \| New Regulations to Phase Out Mercury-Containing Products Announced](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fgazette.gc.ca%2Frp-pr%2Fp2%2F2024%2F2024-06-19%2Fhtml%2Fsor-dors109-eng.html&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301275932%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=6wWzIzjXGPIf1RVjlEsQo0%2B%2F0nzOl1q0bLEfk6XrK0M%3D&reserved=0)
- [MFDS Unveils New Pathways for Food Safety Innovation at APFRAS 2024](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.mfds.go.kr%2Feng%2Fbrd%2Fm_61%2Fview.do%3Fseq%3D164&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301281847%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=BhUl2wFUmaAsjzMXsRTi5J86ezL2kud2N5PxgBg8IPI%3D&reserved=0)

## Mergers & Acquisitions

- [Johnson & Johnson completes acquisition of Proteologix, Inc.](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.jnj.com%2Fmedia-center%2Fpress-releases%2Fjohnson-johnson-completes-acquisition-of-proteologix-inc&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301287540%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=VQ9ZqP1beM83BIj%2FBEeSPV4kG1pYbYbu4sqsfn5oNJU%3D&reserved=0)



## Upcoming Events

- [Pharmacovigilance World 2024](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fcorvusglobalevents.com%2Fconference%2Fpharmacovigilance-world&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301299169%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=9s4DJMRIHa5oS6QKb6yM3jUb3IRbdAnprNRPeZjccLE%3D&reserved=0)
- [in-cosmetics Korea](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.in-cosmetics.com%2Fkorea%2Fen-gb.html&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301304993%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=LgFeziwr6ySPYorjUCQw0TqLJyExgz1sW9Fr0K8iorw%3D&reserved=0)
- [InterCHARM Beauty Expo Korea 2024](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.intercharmkorea.com%2F&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301310524%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=y0%2FJ5nmUiLdbtndYWZyXh5A7Tcf1n6Ptweb3cJqKAtw%3D&reserved=0)

## Blogs

- [Going Global with eCTD 4.0: Japan Takes the Lead](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.freyrsolutions.com%2Fblog%2Fgoing-global-with-ectd-40-japan-takes-the-lead&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301316203%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=Mafy372O%2Bx8kSmLiIWAitt0lZllj%2BQ5qqpzoZYBUGKc%3D&reserved=0)
- [A Comprehensive Guide to Streamline Generic Drug Applications (ANDA) towards FDA](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.freyrsolutions.com%2Fblog%2Fa-comprehensive-guide-to-streamline-generic-drug-applications-anda-towards-fda&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301322010%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=tgAfUZKyFQL2FnaQhs6lFt1C8%2FGBO7ZkXKrQOm6X00Y%3D&reserved=0)
- [Key Considerations for successful IND-BLA Submissions towards Health Authorities](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.freyrsolutions.com%2Fblog%2Fkey-considerations-for-successful-ind-bla-submissions-towards-health-authorities&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301327916%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=%2FpKzaLjzqjNiFvnZN%2B8XA12eXQ%2BMqJnOX6DT7tcn0eU%3D&reserved=0)
- [3 Key Pharma Regulatory Updates in South Korea for 2024](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.freyrsolutions.com%2Fblog%2F3-key-pharma-regulatory-updates-in-south-korea-for-2024&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301333615%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=m2lL6pz6SzTjHj%2Fh8QV%2BPsBQrI%2F4Si1mvLPiisnUWU8%3D&reserved=0)
- [Dispelling Common Misconceptions about Good Pharmacovigilance Practice in the US and Europe](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.freyrsolutions.com%2Fblog%2Fdispelling-common-misconceptions-about-good-pharmacovigilance-practice-in-the-us-and-europe&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301339320%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=D1PV%2BnaYiocvTccAvYvU604R%2FrDTTGPAbrZBbuBZps8%3D&reserved=0)
- [Understanding the Differences Between PADER and PSUR/PBRER in Pharmacovigilance](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.freyrsolutions.com%2Fblog%2Funderstanding-the-differences-between-pader-and-psurpbrer-in-pharmacovigilance&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301344962%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=y%2BhHA7AGZ%2BBWTA49LeTY0fbZ2GfUTWrG1fbOoF9eKl0%3D&reserved=0)
- [Impact of Good Clinical Practice (GCP) on Bioanalytical Study Outcomes](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.freyrsolutions.com%2Fblog%2Fimpact-of-good-clinical-practice-gcp-on-bioanalytical-study-outcomes&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301350922%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=ftdVnGlxI0Ltjm%2FGdr64OWm1%2BaswFyDMUccfj7ulJqE%3D&reserved=0)
- [Understanding the Significance of Applicant/ Sponsors Oversight in Clinical Studies](https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.freyrsolutions.com%2Fblog%2Funderstanding-the-significance-of-applicant-sponsors-oversight-in-clinical-studies&data=05%7C02%7CNizamuddin.Shaik%40FreyrSolutions.com%7C192f31320b944f53e32408dc94579fd4%7Ce1dffae5ca2f4d3fba9531318bc48aae%7C0%7C0%7C638548351301358491%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=z%2BBRCYZYgotTaGvYK1T1ALV6zJmg8%2Fvaj5JHnUud3ys%3D&reserved=0)