50 Years of EU Pharmaceutical Legislation

50 years of EU Pharmaceutical regulation - banner

2015 marks the 50th anniversary of the adoption of the first law on the authorisation of pharmaceuticals at EU level, which set the basis for some of the key principles that are still valid today.

Much of the impetus behind the adoption of the first law on pharmaceuticals at EU level stemmed from the determination to prevent a recurrence of the thalidomide disaster of the late 1950s early 1960s, when thousands of babies were born with limb deformities as a result of their mothers taking thalidomide as a sedative during pregnancy. This experience, which shook public health authorities and the general public, made it clear that to safeguard public health, no medicinal product must ever again be marketed without prior authorisation. Over the past 50 years a large body of legislation has been developed around this principle, with the progressive harmonisation of requirements for the granting of marketing authorisations and post-marketing monitoring implemented across the entire EU.

To mark the 50th anniversary of the adoption of the first EU pharmaceutical law the European Commission is organising a one-day conference that will take place in Brussels on 28 September 2015. The conference will review past achievements while focusing on the present and future role of EU pharmaceutical legislation in protecting the health of citizens in the EU and in the world, and in promoting advances in science, innovation and public health. Despite the many achievements there are still many challenges ahead. Different stakeholders see these challenges but each from different perspectives. The conference wants to bring to surface these different perspectives in an open and stimulating exchange with representatives from national governments, European institutions, national competent authorities, industry, healthcare professionals, academia and patient groups, with the objective of working towards a shared vision for the future.


 
Press statement
Memo
Timelinepdf(106 KB)
e-Timeline
Safety of medicinal products in the EU
Safe medicines for the EU - View the videompeg-4v(9 MB) Choose translations of the previous link български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)

EudraBook V1 - May 2015 - Compendium of EU pharmaceutical law

Conference on '50 years of EU pharma legislation: achievements and future perspectives'
Video recording
Meeting programmepdf(717 KB)
Conference reportpdf(309 KB)