EIPG Comments on Two EMA Papers for Consultation

Leave a comment  

The European Industrial Pharmacists Group is preparing comments on two more documents submitted for consultation by the European Medicines Agency.

The first document is “Scientific guideline: Concept paper on an addendum on terms and concepts of pharmacogenomic features related to metabolism to the Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products (EMA/CHMP/37646/2009), draft: consultation open“. This addendum to the guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products (EMA/CHMP/37646/2009) intends to provide clear definitions of terms used for metabolic phenotyping, as well to propose concepts regarding the translation of genotypes into the predicted metabolic phenotype, of significant importance for the correct treatment of patients. The EMA consultation deadline is the 10th October, 2017. Comments can be submitted before the 5th October to the contact persons of the EIPG Member Associations, or directly to the EIPG Vice-President Technical and Professional Development, Piero Iamartino.

The second document is “Scientific guideline: Draft reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development, draft: consultation open“. The reflection paper provides current regulatory considerations regarding statistical aspects for the comparative assessment of quality attributes in the settings of pre- and post-manufacturing change, biosimilar development as well as generics development. It raises open issues from a methodological perspective addressing questions related to comparison objectives, sampling strategies, sources of variability, acceptance ranges and statistical analysis approaches to conclude on the similarity of two drug products based on quality attribute data. A main objective of the reflection paper is to establish a framework and a common language to facilitate future discussion among stakeholders and to invite comments in relation to the issues raised. The EMA consultation deadline is the 31st March, 2018. Comments can be submitted before the 1st December to the contact persons of the EIPG Member Associations, or directly to the EIPG Vice-President Technical and Professional Development, Piero Iamartino.

Add a Comment