Minutes of CVMP Meeting 8-10 December 2015 published

11 December, 2015

The EMA has posted the press release with details of the CVMP's meeting of 8 – 10 December 2015 (Link). General news relating to regulatory affairs includes:

  • Immunologicals: a new concept paper on guidance on statistical principles for clinical trials for IVMPs was adopted for consultation (Link)
  • Quality: a new Q & A document was adopted on the use of powders and granules in medicinal products composed of 100% active substance (soon to be published)
  • Pharmacovigilance: a new Q & A document was adopted on adverse event reporting (Link)
  • Antimicrobial resistance: following the recent discovery of a gene that can be transferred between different types of bacteria, causing them to become resistant to the antibiotic colistin, the CVMP agreed on the need to update the 2013 advice on the substance
  • General: a new guideline was adopted on the principles for preparing assessment reports for VMPs, to facilitate consistency and coherence (Link)
  • SPCs: a new Question and Answer document on solvents in the product information of VMPs authorised through the centralised procedure was adopted for consultation (Link)
Business Units: 

Regulatory Outsourcing Options

Cyton’s dedicated regulatory procedures team can support you with:
 - Dossier preparation, submission & regulatory procedures
 - Regulatory intelligence and strategic planning
 - Life cycle management
 - Key person cover
 - Pharmacovigilance
 - Brexit support services