2005/0227(COD)COM(2005)567

Advanced Therapy Medicinal Products Regulation

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004

Stage: In force, reached 10 Dec 2007
In force: In force since 30 Dec 2007 · CELEX 32007R1394
Procedure: Regulation · Ordinary legislative procedure
Last activity: 30 Dec 2007

1 act

Delegated and implementing acts beneath it

By status: 1 published.

Act	Kind	Status	Adoption
Implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises	Commission · Regulation	Published

Titles link to EUR-Lex where the act has been published.

14 documents

Documents

Newest first. Each opens at its source.

Text adopted · OJ L 087 31.03.2009, p. 0174Commission · 31 Mar 2009
Text adopted · OJ L 324 10.12.2007, p. 0121Commission · 10 Dec 2007
Text adopted · Regulation 2007/1394Commission · 13 Nov 2007
SEC(2005)1444Commission · 16 Nov 2005
Report · A6-0031/2007Parliament
Text adopted · Corrigendum to final act 32007R1394R(01)Commission
Report · PE371.745Parliament
Committee opinion · PE371.930Parliament
Report · PE374.157Parliament
Committee opinion · PE374.450Parliament
Amendments · PE374.483Parliament
Report · PE380.740Parliament
Amendments · PE382.323Parliament
Text adopted · T6-0144/2007Parliament

Summary

Generated

Regulation (EC) No 1394/2007 sets EU rules for authorizing, supervising and monitoring advanced therapy medicinal products: gene therapy, somatic cell therapy and tissue-engineered products. It requires centralized marketing authorization via the EMA and creates the Committee for Advanced Therapies. It has applied since 30 December 2008.

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Sources: EP Legislative Observatory · EU Law Tracker · EUR-Lex. Record as of 12 Oct 2026. Something wrong on this page? Report an error.

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