Last week’s round -up;
19-23 July 2021

published 27 Jul 2021

New Ph. Eur. Golimumab concentrated solution monograph

The EDQM has released a new draft monograph on a single-source anti-TNF-alpha monoclonal antibody, Golimumab concentrated solution. The Ph. Eur. Commision has used the single-source approach to elaborate this draft monograph and the text reflects the considerations outlined in the EDQM’s scientific publication on “Elaborating European Pharmacopoeia monographs for biotherapeutic proteins using substances from a single source”. The draft monograph is open for public consultation until the 30th September 2021.

Notification for CEP holders: Implementation of Ph. Eur. Supplement 10.6

Ph. Eur. Supplement 10.6 is now available and the EDQM has invited CEP holders to update their applications according to the revised monographs that will be implemented on the 1st January 2022. The Directorate has provided a list of substances covered by a CEP and for which a revised monograph will be implemented, and updates are classified into two categories, “Case A” and “Case B”. “Case A” concerns cases where the specification of the substance should be updated according to the revised monograph. “Case B” concerns amendments to the monograph which require the submission of data to the EDQM. In the article linked below, the EDQM has provided detailed instructions for CEP holders and manufacturers on how to proceed depending on which case the updates relate to.

FDA ICH Q12 EC Pilot Program

ICH Q12 facilitates the management of post-approval CMC changes for new and marketed drug products and drug substances. According to the guideline, regulators will allow manufacturers to identify and submit established conditions (ECs) for new drug applications and prior approval supplements. ECs are defined as “legally binding information considered necessary to assure product quality.” Manufacturers can propose reporting categories for post-approval changes after identification of ECs. In 2019, the US FDA started the EC Pilot Program where sponsors could propose explicit established conditions (ECs) as part of an original new drug application, abbreviated new drug application, biologics license application or as a prior approval supplement.

The following RAPS article outlines the outcome of the pilot program and discusses the different approaches taken by manufacturers when defining ECs:

Revised Ph. Eur. general chapter on chemometric methods applied to analytical data

The revised general chapter Chemometric Methods Applied to Analytical Data (5.21) has been published in Pharmeuropa 33.3 and is open for comments until the 30th September 2021. This general chapter is published for information and is an introduction to the use of chemometrics and data science techniques. Some of the updates in the revised Chapter include: · An update of section 1 ‘General aspects’ with a review of parts of ‘Pre-processing’ and ‘Assessment and validation of chemometric methods’. · Two new sub-sections on ‘Independent component analysis’ and ‘Decision trees and random forests’. · A general review of sub-sections on ‘Similarity measures’, ‘Clustering’, ‘Multiple linear regression’, ‘Principal component regression’, ‘Support vector machines for supervised classification’ and ‘Artificial neural networks’. · A new section, 3. ‘Related application fields’, including sub-sections on ‘Chemometrics in chemical imaging’ and ‘Data fusion’. · An update of the Glossary and the Abbreviations.

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