Let us share some great regulatory tips from Läkemedelsverket (Swedish Medical Products Agency). They have published a list of well-thought-out tips directly from their quality assessors directed to pharma companies. The list details how to compile your quality (CMC) related variation applications in the best way. Take a look:
@https://lnkd.in/denRJuGa
Do you need pharmacovigilance support?
We provide a full pharmacovigilance setup and QPPV to comply with the pharmacovigilance legislation.
We also act as local PV function in the Nordics.
And more.
The RegFile team is back to work and ready for a fresh start! Something we are really looking forward to is the NLS days taking place 18-19 September in Malmö. We will share exhibition booth with our CTR siblings where you are most welcome to visit. There is still time to sign up for NLS if you haven’t already.
See you there! At booth C09
The regulatory “bible” for approved products is changing. Obviously, we are talking about the “EC guidelines on variations categories and procedures”. Be prepared and check out the proposal for stakeholder consultation: european-commission-guidelines-variations-categories-procedures-proposal-stakeholder-consultation-track-changes_en.pdf (europa.eu)
There are many changes in this version, relating to IA super grouping, work-sharing, flexibility for vaccines, addition of API suppliers and more. Read the Executive summary for a complete overview:
executive-summary-proposed-amendments-european-commission-guidelines-variations-categories-procedures_en.pdf (europa.eu)
We will follow the updates closely and make sure to keep you updated.
Are you working on a PIP?
Please note that paediatric submissions must be submitted via the IRIS platform from 4 June 2024.
The following submission types are affected:
• Initial paediatric investigation plan (PIP)
• Modification of PIP
• Product-specific waiver
• Compliance check
• Annual report
• Confirmation on class waiver, or inclusion of an indication
• Discontinuation of paediatric development.
Not familiar with IRIS? We are. Please reach out at info@regfile.se
Buying a complete drug product dossier at an attractive price may be very tempting!
But what are the chances the file is complete and will be pass a marketing authorisation application in Europe?
Let us help. We regularly perform dossier gap analyses against the EU regulatory framework.
RegFile AB
Eklundshovsvägen 1G, 752 37 Uppsala, Sweden
info@regfile.se
