Regulatory Exclusivities
摘要
Regulatory exclusivities are applicable to medicinal products, without distinguishing between different classes of drugs, with the exception of orphan drugs, which are intended for the treatment of rare diseases, and paediatric drugs, which are medicines for the paediatric population. Regulatory exclusivities, both classic and those pertaining to orphan and paediatric drugs, do not specifically address PM drugs. However, PM may benefit from some of these exclusivities.