Regulation (EC) No 726/2004: the EU centralised procedure
The 2004 EU regulation under which every new cancer medicine is assessed once by the European Medicines Agency and authorised for all member states by the European Commission, and which also carries the rules for conditional authorisation and compassionate use.
Overview
European Union, regulation. Regulation (EC) No 726/2004 of 31 March 2004 lays down Union procedures for the authorisation and supervision of medicines and establishes the European Medicines Agency, replacing Regulation (EEC) No 2309/93 which had created the agency in 1995. Its Annex makes the centralised procedure compulsory for medicines for cancer, for biotechnology products and for orphan and advanced therapy medicines. Primary text: EUR-Lex.
How it works: the Committee for Medicinal Products for Human Use (CHMP) assesses the application within 210 active days, with clock stops for questions, and the European Commission issues a decision valid in all member states, plus Iceland, Liechtenstein and Norway, within about 67 days. Article 14-a (formerly Article 14(7)) and Regulation (EC) No 507/2006 provide for conditional marketing authorisation on less complete data for unmet needs, renewed yearly; Article 14(8) allows authorisation under exceptional circumstances; and Article 83 lets member states run compassionate use programmes for medicines under assessment. The EMA's PRIME scheme (2016) for priority medicines is an agency initiative built on the accelerated assessment provision (150 days).
What it changed and the arguments: one assessment instead of up to 27 gave cancer medicines simultaneous legal availability across Europe, though pricing and reimbursement stay national and delay actual access by one to two years. The 2023 pharmaceutical package proposes to replace this regulation, shorten assessment to 180 days and reform the committee structure. The centralised procedure is the model that the UK's international recognition route and Project Orbis both reference.
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