The principal outcome of the R&D endeavour is the successful launch of a new molecular entity (NME) or as it defined in other regions such as Europe, new active substance (NAS). These figures need to be averaged over a longer time period, to smooth over filing patterns which may reflect administrative or policy changes rather than innovative pace. Looking at the figures below in two broad periods, 2007 to 2011 and 2012 to 2016, there is a significant increase in both NMEs and NASs, with the averages moving from 24 to 35 for NMEs and 27 to 39 for NASs.
New Molecular Entity (NME): A new chemical entity or biological (including products of biotechnology) that has not been previously available for therapeutic use in man and is destined to be made available as a ‘prescription only medicine’, to be used for the cure, alleviation, treatment, prevention or in vivo diagnosis of diseases in man. Vaccines, new salts, pro drugs, metabolites and esters of existing compounds and certain biological compounds (e.g. antigens) are not classified as NMEs. Combination products are excluded from the list unless one or more of the constituents of the combination product has never been previously available.
New Active Substance (NAS): A chemical, biological, biotech or radiopharmaceutical substance that has not been previously available for therapeutic use in humans and is destined to be made available as a ‘prescription only medicine’, to be used for the cure, alleviation, treatment, prevention or in vivo diagnosis of diseases in humans. The term NAS also includes: An isomer, mixture of isomers, a complex or derivative or salt of a chemical substance previously available as a medicinal product but differing in properties with regard to safety and efficacy from that substance previously available/ a biological or biotech substance previously available as a medicinal product, but differing in molecular structure, nature of source material or manufacturing process and which will require clinical investigation. A radiopharmaceutical substance that is a radionuclide or a ligand not previously available as a medicinal product. Alternatively, the coupling mechanism linking the molecule and the radionuclide has not been previously available.