Monday Weekly Summary (04.09 - 17.09.2023)

?? Monday Weekly Summary: Stay informed with the latest regulatory updates!

?In the fast-paced world of regulations, staying updated is key to success. We've gathered a comprehensive list of regulatory updates from last week (04.09 - 17.09) to keep you informed about the latest changes in the pharmaceutical industry. Check out the links below for essential insights and ensure compliance with the ever-evolving landscape.

???? Scientific Articles (Open access)

• Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021
• An Exploratory Study of the Impact of COVID-19 Vaccine Spontaneous Reporting on Masking Signal Detection in EudraVigilance

??? Recommendations/Regulations/Guidelines/Instructions/FAQs

• Draft guideline on clinical investigation of medicinal products in the treatment of depression - Revision 3
• Clinical investigation of medicinal products in the treatment of depression - Scientific guideline
• Guidance on paediatric submissions
• User safety of topically administered products - Scientific guideline

?? Reports

• Applications for new human medicines under evaluation by the CHMP: September 2023
• Report on the implementation of the EMA-EUnetHTA 21 work plan 2021 - 2023
• Compilation of Union Procedures on Inspections and Exchange of Information

??Trainings/presentations

• Multi stakeholder workshop on Real World Data RWD
• Quarterly System Demo Q3-2023 – start: 21.09.2023
• User safety of topically administered products - Scientific guideline – start: 20.11.2023
• 2023 09 14 Advanced MedDRA Coding Presented in Spanish

??? News/Press Releases

• CTIS newsflash - 1 September 2023
• CTIS newsflash - 15 September 2023
• EU-Innovation Network Workplan 2023
• National Innovation Offices Contacts
• World Patient Safety Day 2023: Engaging patients for patient safety
• EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna
• Network Portfolio Roadmap 2023-2025
• Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies
• List of industry subject matter experts and list of planned calls for industry subject matter experts
• Stakeholder participation in information management

??? Meeting agendas/minutes/summary

• Management Board meeting: 7-8 June 2023
• Eleventh Nitrosamine Implementation Oversight Group (NIOG) meeting, Online, from 12/07/2023 to 12/07/2023
• Minutes of the CHMP meeting 19-22 June 2023
• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023, CHMP, 15/09/2023
• Agenda of the CAT meeting 6-8 September 2023
• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023

??Product opinion/decisions/updates

• Flurbiprofen : List of nationally authorised medicinal products - PSUSA/00001450/202211
• Flurbiprofen : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001450/202211
• Sertindole : List of nationally authorised medicinal products - PSUSA/00002695/202301
• Levobupivacaine : List of nationally authorised medicinal products - PSUSA/00001848/202212
• Lamotrigine : List of nationally authorised medicinal products - PSUSA/00001825/202211
• Lamotrigine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001825/202211
• Cimicifuga racemosa (L.) nutt., rhizoma : List of nationally authorised medicinal products - PSUSA/00000755/202301
• Cilostazol : List of nationally authorised medicinal products - PSUSA/00010209/202301
• Pandemic Influenza Vaccine H5N1 Baxter : EPAR - Public assessment report
• Recommendation for maintenance of orphan designation at the time of addition of new indications to the marketing authorisation: Votubia (everolimus) for the treatment of tuberous sclerosis
• Referral: Havrix, hepatitis A virus (inactivated, adsorbed), associated names: Havrix and associated names, Article 30 referrals, Procedure started, 14/09/2023
• Referral: Mysimba, naltrexone, bupropion, Article 20 procedures, Procedure started
• EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep, CHMP, 15/09/2023
• Information from the Polish HA President, regarding the review of data on the potential risk of neurodevelopmental disorders in children of men treated with valproate within 3 months before conceiving a child.

?? Other

• Records of data processing activity for the user test of the Critical Medical Device Shortages (CMDS) system
• EudraVigilance Expert Working Group (EV-EWG) Work Programme 2023- 2024
• Timetable: Safety referral (Article 107i, urgent Union procedure)
• Timetable Safety referrals (Art 20 and Art 31PhV1)
• Timetable – non safety referral

#AIDIFY #RegulatoryUpdates #PharmaIndustry #StayInformed #ComplianceMatters

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