BREXIT

Last week’s round-up, 21 – 25 October 2019

By Tessa Fiorini-Cohen and Marthese Mifsud

 

EMA to Cease Printing and Dispatching of CPPs During Relocation to Permanent Building

25 Oct 2019

The EMA will temporarily cease printing and dispatching of Certificates of Pharmaceutical Products (CPPs) during relocation to its permanent building.

This temporary suspension will take place between 13th December 2019 and 18th January 2020.  Urgent requests may be submitted to the EMA by close of business on the 9th December in order to be dispatched by close of business on the 13th December. Standard requests need to be submitted by close of business on the 8th November for dispatch by the same date.

The EMA has stated that these dates are subject to change depending on the demand for certificates: http://bit.ly/RealGenerics-2qF2kmZ

 

“No deal” Brexit and life sciences: What happens?

24 Oct 2019

What actions should pharmaceutical companies follow to ensure they’re prepared for a no-deal Brexit?

In the scenario of a “no deal”, the UK will immediately self-regulate medicines, with implications for marketing authorisations, orphan medicinal product status, clinical trials, medical devices and more.

With this in mind, companies should be able to map out which and how many rights they’d lose on Brexit day if no action is taken, and what actions they need to take to prevent such loss. The following article proposes a handy step plan for life science companies to ensure that they’re prepared for Brexit day: http://bit.ly/RealGenerics-2W8SZj6

 

Comparator products in Bioequivalence/Therapeutic Equivalence studies after Brexit

23 Oct 2019

The MHRA has published new Brexit-related guidance on comparator products used in bioequivalence studies.

The guidance explains that it will be possible to use non-UK sourced comparator products in studies supporting abridged marketing authorisation applications, in the case of a no-deal Brexit. However, the application would still need to refer to an eligible UK reference medicinal product and show that any differences between the two products would not be therapeutically significant.

Comparator products can be shown to be identical to, or representative of, the reference medicinal product. The guidance details expectations for both demonstration of identicality and representativeness, including requirements within the common technical dossier and analytical considerations. The MHRA has recommended that they are consulted for scientific advice in the case of complex products: http://bit.ly/RealGenerics-2W5DMPM

 

Assessing effects of drugs in wastewater on aquatic wildlife

22 Oct 2019

Human pharmaceuticals may affect hormonal pathways in aquatic wildlife when discharged into wastewater, and recent research has assessed this possibility within the US.

Around 175 pharmaceuticals were predicted to affect oestrogen pathways in fish and other aquatic vertebrates. Concentrations of each drug at the point of entry into local aquatic environments were then estimated, by assuming that the entire sales volume of the drug in a year was excreted into the annual US volume of wastewater discharged from sewage treatment plants.

Using these values, the researchers then calculated the concentration of each of the 175 drugs that would reach fish tissue, using a model specific to fish and a number of assumptions. Four drugs showed the potential to accumulate in fish tissue to levels that would affect their oestrogen pathways: 7α-ethinylestradiol, 17β-estradiol, raloxifene and bazedoxifene. The methodology could serve as a model for similar assessments of the effects of wastewater pharmaceuticals on wildlife: http://bit.ly/RealGenerics-35ZlOTQ

 

The EMA’s Q&A on nitrosamines for marketing authorisation holders has been updated.

21 Oct 2019

The Q&A now includes an additional question, ‘What are the currently identified root causes for the presence of nitrosamines?’ The answer identifies seven potential sources, including use of sodium nitrite with particular reagents in the same or different process steps, use of contaminated or recovered raw materials, cross-contamination between products manufactured on the same line, degradation processes, and use of certain packaging materials: http://bit.ly/RealGenerics-32uAJmC

 

Image: #BREXIT, CC BY 2.0

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