Safety by Design: EMA Reflection Paper on Development of Medicines for Use in the older Population

The European Medicines Agency (EMA) recently released a draft Reflection Paper on the pharmaceutical development of medicines for use in the older population. The deadline for comments is January 31, 2018.

With the publication of the Reflection Paper the EMA has opened the next chapter of population-specific product development and design to increase the medicine’s efficacy and safety. The EMA says, the Reflection Paper is not intended to provide regulatory or scientific guidance. However, it applies to "any new application for a marketing authorization (MA) or variation to an existing MA, and for all application types including full and abridged MAs" as well as "during the clinical trial phases and in the post-authorization phase as part of the product life-cycle management." The considerations may also be of relevance to other populations suffering from similar impairments and/or needs (e.g. an easy to open packaging is relevant for rheumatic patients of any age).

The agency seeks specific feedback (either supportive or with a proposal for revision) for the points below:

  • The format of this document which is written as a reflection paper intended to bring together the available evidence and to support discussion on the topics raised, rather than a guideline which would be intended to provide technical and regulatory requirements.
  • The target audience of the paper. Currently a wide audience is considered (e.g. drug developers in industry and academia; quality assessors in regulatory agencies; patients and patient representatives; other medicinal product experts in industry and regulatory agencies).
  • The use of the term ‘older patient/people/population’ versus ‘the elderly’.
  • The reflections on the accuracy of tablet breaking, the minimum data in regulatory submissions on the administration of medicines through feeding tubes and multiple compliance aids / multiple drug dispensing systems.

Beside the sections regarding specific aspects of the different routes of administration and dosage forms, the 19-page document deals with considerations related to Dosing Frequency, Excipients, Devices and Technologies, Product Information, and Medication Management.
According to the draft document, common problems regarding Devices and Container Closure Systems (CCS) relate to difficulties in handling devices and opening containers. Where appropriate, human factor studies are conducted. "Companies are reminded that child resistant containers should be suitable for opening by older people according to ISO standards." To ensure the stability of products in a diversity of Multi-compartment Compliance Aids (MCAs) and Multi Dose Dispensing systems (MDDs), companies are encouraged to study the stability of products that are likely to be used in the older population outside the authorized CCS for short periods of time at ambient conditions (e.g. 1 month at 25°C/60%RH) and to clearly reflect the results in the Summary of Product Characteristics / Package Leaflet (SmPC/PL).

Finally, the draft contains two Annexes: Annex 1 summarizes characteristics on older people requiring particular consideration in the pharmaceutical development of medicines for use in the older population. A glossary is included as Annex 2.

For more detailed information please see the first version of EMA's "Reflection paper on the pharmaceutical development of medicines for use in the older population" on the EMA website.

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