title: Regulatory incentives to ensure better medicines for older people: From ICH E7 to the EMA reflection paper on quality aspects.
abstract: Ageing comes with an increased propensity in the alteration of human organ and body functions, which can e.g. result in multi-morbidity, frailty, polypharmacy, altered medication safety and/or efficacy, and problems with the practical use of medicines in a real world setting. Such problems may e.g. involve difficulties opening containers, swallowing large tablets, breaking tablets by hand, or correctly understanding the user instruction. This review aims to summarize the European regulatory activities towards better medicines for older people, with a main focus on formulation development and the overall drug product design. It addresses the ICH E7 guideline "Studies in support of special populations, geriatrics", the ICH Q8 guideline "Pharmaceutical development", the EMA good practice guide on "Risk minimisation and prevention of medication errors" and the forthcoming EMA CHMP QWP reflection paper on the "Quality aspects (pharmaceutical development) of medicines for older people". In addition, three key aspects to the practical use of medicines by older people are discussed in a wider context: multi-particulates including small tablets (also referred to as mini-tablets), ease of opening and storage conditions. Furthermore, attention is paid to work in progress e.g. incentives by the European national drug regulatory authorities, and patient centric drug product development.
authors.affiliation: Medicines Evaluation Board (MEB), Quality Department, Utrecht, The Netherlands. Electronic address: da.v.riet@cbg-meb.nl.
authors.forename: Diana A
authors.initials: DA
authors.lastname: van Riet-Nales
authors.affiliation: Medicines & Healthcare products Regulatory Agency (MHRA), Vigilance and Risk Management of Medicines Division, Special Populations Group, London, United Kingdom.
authors.forename: Nasir
authors.initials: N
authors.lastname: Hussain
authors.affiliation: Medical Products Agency (MPA), department of Pharmaceutics and Biotechnology, Uppsala, Sweden.
authors.forename: Katarina A E
authors.initials: KA
authors.lastname: Sundberg
authors.affiliation: Swissmedic, Swiss Agency for Therapeutic Products, Department of Marketing Authorization, Division Quality Review, Bern, Switzerland.
authors.forename: Doris
authors.initials: D
authors.lastname: Eggenschwyler
authors.affiliation: Human Medicines Evaluation Division, Specialised Scientific Disciplines Department, Quality Office, European Medicines Agency, London, United Kingdom.
authors.forename: Cristina
authors.initials: C
authors.lastname: Ferris
authors.affiliation: Laboratoire National de Santé, Luxembourg.
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Robert
authors.affiliation: Human Medicines Research and Development Support Division, Scientific Advice, London, United Kingdom.
authors.forename: Francesca
authors.initials: F
authors.lastname: Cerreta
mesh_terms: D000368:Aged; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000379:methods; D015195:Drug Design; D055808:Drug Discovery / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards; D004348:Drug Labeling / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards; D004356:Drug Storage / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards; D005060:Europe; D005853:Geriatrics / Q000379:methods / Q000592:standards*; D006801:Humans; D008508:Medication Errors / Q000331:legislation & jurisprudence / Q000517:prevention & control; D009042:Motivation; D013607:Tablets / Q000592:standards
chemical_list: D013607:Tablets
keywords: Aged [MesH]; Chemistry, pharmaceutical [MesH]; Drug approval [MesH]; Drug product design; EMA; Formulation; Guideline; Medication management; Mini-tablet; Older people; Reflection Paper