The EMA welcomes the political agreement between the European Commission, the European Parliament and the Council of the EU on a comprehensive reform of EU pharmaceutical legislation, which it considers to be a historic milestone for the regulation of medicines and patients in the EU[3]. The new legislation will modernise the way medicines are developed, authorised and made available to patients across the EU and simplify structures and procedures put in place by a number of previous pieces of legislation[3]. The EMA will simplify its expert structure from five to two scientific commissions for medicinal products for human use: the Commission for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC)[3]. The reform will shorten assessment periods - the aim is to reduce the standard assessment period from 210 to 180 days - and introduce mandatory electronic submission of applications and electronic product information[2][5]. Permanent authorisations will be valid by default for an indefinite period of time, with renewal only required for safety concerns identified by the EMA's scientific panels[2]. The reform will also allow the introduction of tailored frameworks for non-standard categories of medicines (e.g. personalised therapies) and the creation of a 'regulatory sandbox' to test requirements for innovative medicines[3][2]. The new rules also include eight years of data and market protection with possible extensions for medicines addressing unmet medical needs, which has implications for the market entry of generics and biosimilars[1][2]. The EMA expects the reform to provide more capacity for early scientific support to developers and for better collaboration with health technology assessment (HTA) bodies to speed up patient access to new medicines[3][2].