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(12) Safe and efficacious medicinal products that treat, prevent or diagnose diseases which cause public health emergencies, should be identified, developed, notably through joint efforts by public authorities, the private sector and academia, and made available to Union citizens as soon as possible during such emergencies. The COVID-19 pandemic has also highlighted the need to coordinate assessments and conclusions on multinational clinical trials, in line with what was done on a voluntary basis by clinical trials experts of Member States prior to the date of application of Regulation (EU) No 536/2014 of the European Parliament and of the Council Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1). , and the need for Union-level advice on the use of medicinal products in national compassionate use programmes or the use of medicinal products for indications that are not covered by the marketing authorisation in the Union, in order to avoid delays in the implementation of results of research and in the development and availability of new or repurposed medicinal products.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.