Advanced therapy medicinal product meaning

EU legal framework governing medicinal products A sophisticated network of requirements and guidance, developed at EU level and by EU Member States, shapes oversight of medicinal products, covering: clinical evaluation (ie clinical trials) market entry (ie marketing authorisation (MA) and the regulatory procedure for approving medicinal products and variations to existing MAs) protection of pre-clinical and clinical data generated to obtain an MA (ie regulatory data protection) manufacture and importation labelling and the package leaflet advertising and promotion wholesale distribution and brokering pharmacovigilance pricing and reimbursement falsified medicines medicines for rare diseases (ie orphan medicinal products (OMPs)) paediatric medicines advanced therapy medicinal products (ATMPs) unlicensed medicines and off-label use of authorised medicines EU legal framework Law in these areas has expanded quickly at EU level, driving greater harmonisation across many fields. Nevertheless, Member State rules and guidance remain vital to the overall regime, and there are significant differences between...

C–D | E–H | I–N | O–P | Q–V. Accelerated assessment Many countries provide a regulatory route that speeds up the appraisal of certain medicinal products, helping them reach patients sooner. In the EU, this accelerated assessment significantly shortens the period for the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to examine a marketing authorisation (MA) application from 210 to 150 evaluation days overall. An application can be considered for this pathway where the CHMP judges the product to be of major relevance for public health and therapeutic innovation. See Practice Note: Marketing authorisations in the EU—regulatory procedures for approval of medicinal products—EU centralised authorisation procedure. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) provides a 150-day review for all high‑quality new MA applications to hasten equitable access to new medicines for UK patients. The MHRA assesses applications for a UK, Great Britain (England, Wales and Scotland) or Northern Ireland MA and delivers its considered view on whether to grant...

Good manufacturing practice (GMP) Producers of medicinal products must adhere to defined minimum standards during manufacture. Collectively, these standards are called good manufacturing practice (GMP). GMP ensures medicines are consistently high in quality, suitable for their intended purpose, and compliant with the conditions of the marketing authorisation (MA) or clinical trial authorisation (CTA). The principles of GMP apply to the manufacture of human and veterinary medicinal products, to the active substances used within such products, and to investigational medicinal products (IMPs) (i.e. medicines used in clinical trials). This Practice Note reviews the legislation and guidelines that regulate the manufacture of medicinal products for human use, active substances and IMPs in the EU and the UK. References in this Practice Note to Member States include the Member States of the EU as well as Iceland, Liechtenstein and Norway (EEA countries). For details on how coronavirus (COVID-19) affected regulation of medicinal product manufacturing, see Practice Notes: Coronavirus (COVID-19)—regulatory implications for the UK and European life sciences industry [Archived], Coronavirus (COVID-19)—EU life...