title: Quality considerations of paediatric investigation plans for monoclonal antibodies: A regulatory perspective from the MHRA.
abstract: Since the advent of the EU Paediatric Regulation in 2007, 78 of the 1688 Paediatric Investigation Plans (PIPs) have been for monoclonal antibodies (Mabs). Of these, 22 have been assessed by the MHRA. The purpose of this mini-review is to aid those researching and developing this class of drugs to better understand regulatory concerns leading to improved medicinal products for children. Three principal quality issues were identified for PIPs under Article 7 and 8: i) the level of anti-aggregation stabilisers, ii) acceptability and tolerability of administration (i.e. multiple injections, infusion time and volume), and iii) the need to develop new presentational forms (e.g. pre-filled syringe). Overall, two types of concerns were ascertained - those which are potentially avoidable (e.g. through development of new presentational forms) and others which require the evolution of new technologies in the sector (e.g. production of concentrated, stabilised preparations).
authors.affiliation: Paediatric Unit, Special Populations Group, Vigilance and Risk Management of Medicines Division, Medicines and Healthcare products Regulatory Agency (MHRA), 151 Buckingham Palace Road, London SW1W 9SZ, United Kingdom. Electronic address: nasir.hussain@mhra.gsi.gov.uk.
authors.forename: Nasir
authors.initials: N
authors.lastname: Hussain
authors.affiliation: Paediatric Unit, Special Populations Group, Vigilance and Risk Management of Medicines Division, Medicines and Healthcare products Regulatory Agency (MHRA), 151 Buckingham Palace Road, London SW1W 9SZ, United Kingdom.
authors.forename: Angeliki
authors.initials: A
authors.lastname: Siapkara
authors.affiliation: Paediatric Unit, Special Populations Group, Vigilance and Risk Management of Medicines Division, Medicines and Healthcare products Regulatory Agency (MHRA), 151 Buckingham Palace Road, London SW1W 9SZ, United Kingdom.
authors.forename: Sarah
authors.initials: S
authors.lastname: Branch
mesh_terms: D000911:Antibodies, Monoclonal; D002648:Child; D033161:Government Regulation; D006801:Humans; D007880:Legislation, Drug; D010372:Pediatrics / Q000331:legislation & jurisprudence*; D011787:Quality of Health Care; D006113:United Kingdom
chemical_list: D000911:Antibodies, Monoclonal
keywords: Children; Injectable; MHRA; Monoclonal antibodies; Paediatric investigation plan; Regulation