Last week’s round-up, 06-10 April 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud

Ph. Eur. launches a public consultation on a new general chapter for the analysis of N-nitrosamines

09 April 2020

The new Ph.Eur. general chapter on the analysis of N-nitrosamine impurities in active substances (2.4.36) published in the Pharmeuropa 32.2 is open for public consultation from April to June 2020.

The chapter focuses on the analysis of N-nitrosamines in angiotensin-II-receptor antagonists containing a tetrazole group, including valsartan, losartan potassium, candesartan cilexetil, irbesartan and olmesartan medoxomil. As of April 2021, the manufacturers of these active substances are required to implement a control strategy which ensures that the batches of active substance produced should not contain quantifiable amounts (less than 0.03 ppm) of N-nitroso-dimethylamine (NDMA) and N-nitroso-diethylamine (NDEA), the two main N-nitrosamine impurities.

Maternal paraben exposure linked to overweight development in female offspring

08 April 2020

New research has shown that the use of cosmetics containing butylparaben during pregnancy may be linked to an increased risk of obesity in children.

Parabens are found in many cosmetics including certain creams and body lotions, where they act as preservatives by inhibiting microbial growth. Studies have shown that exposure to parabens during pregnancy may lead to epigenetic changes that affect appetite regulation in children, especially in girls. These findings have prompted researchers to warn expectant mothers against the use of paraben-containing products during pregnancy and breast-feeding.

CMDh updates

07 April 2020

The CMDh has updated the following documents:

– Q&A – Generic Applications: A generic medicinal product cannot apply for fewer modes of administration than recommended for the reference medicinal product in its SmPC.

– Requirements on Submissions (number and format) for New Marketing Authorisation Applications within MRP, DCP and National Procedures and Requirements on submissions (number and format) for Variations and Renewals within MRP and National Procedures: Several updates were made to these requirements, including that Italy now accepts submissions via CESP.

– The following validation checklists have been updated: RMS and CMS Validation Checklists for human medicinal products in DCP, and the CMS validation checklist in MRP.

– The revised guideline on the Applicant’s response document in Mutual Recognition and Decentralised procedures for Marketing Authorisation Applications includes several updates.

Advancing regulatory science in the EU – new strategy adopted

06 April 2020

The EMA has released a ‘Regulatory Science Strategy to 2025’, which provides a plan for advancing human and veterinary regulatory science over the next five years.

One of the fundamental principles of the strategy is to enhance the engagement of all stakeholders and partners involved in the development and supervision of medicines in the EU and globally. This is considered necessary due to the fast pace of innovation in recent years, the development of increasingly complex medicines and the current public health crisis brought on by the COVID-19 pandemic.

The document identifies the following five key strategic goals for such engagement for medicines and proposes core recommendations and underlying actions to support these:

  • Catalysing the integration of science and technology in medicines development
  • Driving collaborative evidence generation – improving the scientific quality of evaluations
  • Advancing patient-centred access to medicines in partnership with healthcare systems
  • Addressing emerging health threats and availability/therapeutic challenges
  • Enabling and leveraging research and innovation in regulatory science

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