News

Last week’s round-up;
03-07 August 2020

published 10 Aug 2020

Common excipients more active than thought

Common ‘inactive’ excipients may be more active than currently thought. Using a combination of computer modelling and lab testing, researchers investigated 639 excipients in the FDA’s Inactive Ingredient Database, screening them against thousands of potential human targets. Overall, 38 excipients were identified as having 134 activities against 44 physiologically relevant targets. Half of these activities were more potent than the on-target activity of some small-molecule drugs. In further testing, seven of these excipients were orally dosed in rats and systemic exposure was assessed. Two of these – cetylpyridinium chloride and thimerosal – reached sufficient concentrations to theoretically modulate their target: https://bit.ly/RealCMC-3gCvyIt

CMDh meeting report – July 2020

A report from the CMDh meeting held in July 2020 has been published. Some of the topics covered during the meeting include: • Brexit • EMA review of dexamethasone for treating COVID-19 • Update on nitrosamines in medicines and medicines containing metformin • Recommendations on common regulatory approaches for allergen products • Update of the RMS Day 70 and Day 120 overview assessment report templates and new RMS similarity assessment report template • Update of examples for acceptable and not acceptable groupings for MRP/DCP products • Questions and Answers on QP declaration • An overview of new applications, variations and renewals related to MRP/DCP that were submitted or finalised during June 2020.

The full CMDh report may be viewed at the following link: https://bit.ly/RealCMC-3gDgIBq

EC releases checklists for reusable and re-sterilisable Medical Devices

The EC released the Compliance and Enforcement Group (COEN) document COEN Working Group -2014 V1.0 on the 28th July 2020. The document includes checklists “Instruction for Use (IFU)” based on EN ISO 17664 & checklist “Assessment of the Validation” based on EN ISO 14937 in Annex 1 and Annex 2 of the document respectively. Checklist “Instruction for Use (IFU)” provides a quick and reliable way to assess IFU in view of making an informed decision on using or purchasing a specific re-sterilisable medical device (RMD). Checklist “Assessment of the Validation” of RMD’s is primarily for manufacturers of Class I devices and allows them to see the criteria adopted by CA for the assessment of validation.

The checklists can be accessed via this link: https://bit.ly/RealRegulatory-3gzuogC

Ph. Eur. Supplement 10.3 – CEP Updates

Ph.Eur. Supplement 10.3 is available and includes a list of substances covered by a CEP and for which a revised monograph will be implemented on the 1st January 2021. CEP holders are invited to update their applications according to the revised monographs. Further information and the list of substances with a revised monograph may be viewed at the following link: https://bit.ly/RealCMC-3i3l4Cb

Recommendations on common regulatory approaches for allergen products

The CMDh has issued guidance for harmonising regulation of medicinal allergen products across the EU, as they are currently authorised and distributed on different legal bases across member states.

https://bit.ly/RealRegulatory-31eKlCF

Butylparaben to be phased out

Butylparaben, a chemical used in pharmaceuticals, cosmetics and personal care products, has been added to the Candidate List of substances of very high concern (SVHCs) and will gradually be phased out due to its endocrine-disrupting properties. The Candidate List includes substances of very high concern that may have serious effects on our health or environment, and which will eventually be phased out. Companies that have a substance on the list may have certain legal obligations to fulfil. As of January 2021, companies are obliged to notify products containing SVHCs to the European Chemicals Agency’s (ECHA) upcoming SCIP database on substances of concern in articles and products.

https://bit.ly/RealCMC-31b9K01