Last week’s round-up, 25-29 November 2019

By Stephanie Allampalli and Marthese Mifsud


EMA to Implement Ombudsman’s Recommendations on Avoiding Bias

29 November 2019

The EMA has announced that it will be following the recommendations of EU ombudsman Emily O’Reilly, following an inquiry regarding the perception of bias in MA assessments. The inquiry was carried out due to concerns that interactions between the EMA and pharmaceutical companies during the pre-submission phase may influence the outcome of MA applications.

EMA’s Executive Director, Guido Rasi, has said that the EMA will be implementing new procedures to ensure separation between the experts providing scientific advice early in the pre-submission phase and the rapporteurs who are involved in MA evaluations of the same drug product. A log of scientific advice will also be added to the European Public Assessment Report (EPAR), including a list of coordinators who provide advice.

ICH Updates After Singapore Assembly Meeting

28 November 2019

During an ICH Assembly meeting held in Singapore earlier this month, three new guidelines were adopted:

  • Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
  • E9(R1): Addendum to Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analyses
  • M9: Biopharmaceutics Classification System-Based Biowaivers

Several concept papers and business plans covering various ICH topics were also finalized.

A new working group will also be focussing on the assessment and control of extractables and leachables for pharmaceuticals and biologics. Newly elected members of the ICH Assembly and ICH Management Committee were also announced during the meeting.

CMDh Best Practice Guide on Multilingual Packaging

27 November 2019

The CMDh has published a best practice guide on multilingual packaging for medicinal products marketed in the EU. The aim of multilingual packaging is to maintain medicinal products in the EU markets, especially within the smaller markets.

The use of multilingual text in pharmaceutical packaging is permitted under Directive 2001/83/EC, Article 63, as long as the same information appears in all the languages used. However, any additional national specific information should appear in the ‘blue box’.

The CMDh document gives guidance for multilingual packages for MR/DCP products, however, the guide may also be used for national products that already have harmonised product authorisation details, such as the SmPC. Applicants are still advised to refer to the additional national guidance referenced in the guide, as this guidance may not be applicable in every aspect for all the member states.

Information for the package leaflet regarding ethanol

27 November 2019

The EMA has published the ‘Information for the package leaflet regarding ethanol used as an excipient in medicinal products for human use’ (EMA/CHMP/43486/2018), mainly to include the potential effects of ethanol in children.

The document notes that the effect of long-term exposure to low levels of ethanol found in medicines has not been evaluated in children. High alcohol consumption during pregnancy may result in foetal alcohol syndrome, which suggests that chronic ethanol exposure during childhood may also affect development. The revised package leaflet for ethanol advises that caution should be taken when co-administering medicines containing propylene glycol or ethanol in children to prevent accumulation of ethanol and its associated adverse effects.

The document also advises that when appropriate the SmPC/PIL of ethanol-containing medicines for cutaneous use should warn that ‘In neonates (pre-term and term newborn infants), high concentrations of ethanol may cause severe local reactions and systemic toxicity due to significant absorption through immature skin (especially under occlusion)’.

Brexit Costs EMA Almost €60M in 2019

25 November 2019

In 2019 Brexit has cost the EMA almost €60M due to the relocation of the agency headquarters from London to Amsterdam.

Through this relocation the available staff at the agency has decreased by about 20%. The EMA has said that “In order to be best prepared to address future challenges with the existing workforce, EMA is reviewing its organisational structure and looking to set up task forces that will focus on key priorities for the European medicines regulatory network such as digital business transformation, data analytics and methods, regulatory science and innovation and clinical trials and manufacturing strategy”.

Once Brexit is complete, the UK will become a third country and will no longer be a (co)-rapporteur for new MA applications through the centralized procedure. As a result, in order to reduce drug shortages, the EMA has had to re-distribute the UK’s centrally authorized medicines to rapporteurs and co-rapporteurs. According to the EMA the number of medicines at risk of shortages has decreased from 108 to 39 (25 human medicines and 14 veterinary products).

Image: children, CC BY-SA 2.0

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