The EMA has now published the following documents adopted in the November meeting of the CVMP:
Draft reflection paper released for consultation
- QUALITY: Chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances (Link).
- QUALITY: revised guideline on process validation for finished products – information and data to be provided in regulatory submissions (Link).
In addition, the EMA has also released the following documents:
- Type II variations Q & A: What pre-submission steps will apply to my Type II variation? (Link).
October monthly report on application procedures, guidelines and related documents for VMPs (Link), which includes the following:
- Summary of procedures processed (MA applications, variations, MRL applications, Scientific Advice given, referrals etc)
- List of all opinions to date in 2016
- List of all MRLs established in 2016
- List of guidelines and working documents, including drafts, adopted in 2016