Commentary on the EMA reflection paper on the pharmaceutical development of medicines for use in the older population

Abstract

Funding information Medicines Evaluation BoardOlder people are often affected by impaired organ and bodily functions resulting in multimorbidity and polypharmacy, turning them into the main user group of many medicines. Very often, medicines have not specifically been developed for older people, causing practical medication problems for them like limited availability of easy to swallow formulations, easy to open packaging and dosing instructions for enteral administration. In 2020, the European Medicines Agency (EMA) published a reflection paper 'Pharmaceutical development of medicines for use in the older population', which discusses how the emerging needs of an ageing European population can be addressed by medicines regulation. The paper intends to help industry to better consider the needs of older people during pharmaceutical/clinical medicines development by summarising data on the most relevant topics, providing early suggestions on how to move forward and prompting expert discussions and studies into knowledge gaps. Topics include patient acceptability, (dis)advantages of an administration route, formulation, dosage form, packaging, dosing device and user instruction. While the paper is directed at older people and the pharmaceutical industry, the reflections

Three-Dimensionally Printed Vaginal Rings: Perceptions of Women and Gynecologists in a Cross-Sectional Survey

“…The European Medicines Agency defines acceptability as the overall ability and willingness of the patient to use the medicine as intended [47,48]. Preference describes the option of choice for product attributes (such as color, odor, viscosity, shape), dosage forms (tablets, implant, VR, gel), delivery routes, or even modes of administration that best suit the individual profile [49].…”

Exploring the Potential of 3d Printing in Pharmaceutical Development

“…In 2015, Spritam (levetiracetam), a medication used to treat epilepsy received Food and Drug Administration (FDA) approval. [107] Since then, several other 3D-printed medications have received approval, including medication for Parkinson's disease produced by GlaxoSmithKline. The FDA released guidelines for the 3D printing of medical devices in 2017, offers suggestions for design, production and testing.…”

“…This draft guidance is broadly organized into two topic areas such as Design and Manufacturing Considerations and Device Testing Considerations [117]. The FDA released drafted guidance also offers suggestions for labelling and premarket filings [107].…”