Advanced therapies - Major developments

Tissue Engineering, Cell Therapy and Gene Therapy

You will find below all information related to this Commission initiative. For any questions, please contact sanco-pharmaceuticals-d5@ec.europa.eu


01/04/2014
 Report on the application of the Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Productspdf(301 KB) Choose translations of the previous link български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) hrvatski (hr) 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)

The European Commission has adopted a Report on the application of the Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products (“ATMP Regulation”).  pdf(301 KB) Choose translations of the previous link български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) hrvatski (hr) 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) In the report, the Commission takes stock of the situation of advanced therapy medicinal products in the EU and analyses the impact of the Regulation on advanced therapies.

 

22/05/2013
Summary of the responses to the public consultation on the Regulation on Advanced Therapies.pdf(92 KB)

A summary of the responses to the public consultation on the Regulation on Advanced Therapies as well as the responses can be found   here.

 

20/12/2012
Public consultation on advanced therapy medicinal products

Stakeholders are invited to provide their views on the application of the Advanced Therapy Regulation at SANCO-ADVANCEDTHERAPY-REPORT@ec.europa.eu.  The consultation will be open until 31 March 2013.

23/09/2009
Implementation of the Advanced Therapies Regulation
Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products
Commission Directive 2009/120/EC of 14 September 2009 amend the Annex to Directive 2001/83/EC by updating the definitions and detailed scientific and technical requirements for gene therapy medicinal products and somatic cell therapy medicinal products and establishing technical requirements for tissue engineered products, as well as for advanced therapy medicinal product containing devices and combined advanced therapy medicinal products. It has been published in the Official Journal on 15 September 2009 and shall enter into force on the twentieth day after publication. The text of the Regulation is available here.
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2/03/2009
Commission Directive regarding advanced therapy medicinal products approved by Standing Committee

On 2 March 2009, the Member States have approved the new Commission Directive amending, as regards advanced therapy medicinal products, Annex I to Directive 2001/83/EC. The draft Directive was put to vote at a meeting of the Standing Committee on Medicinal Products for Human Use.
The text now enters a 3-months period of scrutiny by the European Parliament and Council, before it can be formally adopted by the Commission and enters into force.

The text of the draft Directive which was voted on 2 March 2009 is available herepdf .

Update 22/7/2008: Implementation of the Advanced Therapies Regulation: public consultation on the Revised Clinical Trial Application Form as regards advanced therapy investigational medicinal products

Annex 1 to the 'Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial' defines the standard template for the Clinical Trial Application (CTA) form. It is necessary to amend this form in order to incorporate the changes entailed by Regulation (EC) No 1394/2007 on advanced therapy medicinal products. This public consultation document includes the draft amendments. The public consultation paper is available herepdf(61 KB) .

Changes compared to the current version of the CTA form are highlighted.

Comments on this document should be e-mailed before 15 October 2008 to sanco-pharmaceuticals@ec.europa.eu

Update 9/7/2008: Implementation of the Advanced Therapies Regulation: Outcome of the Public Consultation on amendments to Annex I to Directive 2001/83/EC

From 8 May to 10 June 2008, a public consultation was conducted on draft amendments to Annex I to Directive 2001/83/EC as regards advanced therapy medicinal products.
The summary outcome of the public consultation paper is now available herepdf(27 KB).

Update 9/7/2008: Implementation of the Advanced Therapies Regulation: Outcome of the Public Consultation on the Certification Of Quality & Non-Clinical Data For Small And Medium-Sized Enterprises

From 5 May to 4 July 2008, a public consultation was conducted on provisions for certification of quality and non-clinical data for small and medium-sized enterprises (SMEs), pursuant to Article 18 of Regulation (EC) No 1394/2007.
The summary outcome of the public consultation paper is now available herepdf(35 KB)..

Update 4/7/2008: Implementation of the Advanced Therapies Regulation: public consultation on good clinical practice specific to advanced therapy medicinal products.

Regulation (EC) No 1394/2007 on advanced therapy medicinal products will apply from 30 December 2008. Article 4 of the Regulation requires that detailed guidelines on good clinical practice (GCP) specific to advanced therapy medicinal products be drawn up. This public consultation document presents preliminary proposals to draft such guidance. The public consultation paper is available herepdf(69 KB)

Contributions to this public consultation should be sent by e-mail to sanco-pharmaceuticals@ec.europa.eu, before 15 October 2008.

Update 7/5/2008: Implementation of the Advanced Therapies Regulation: public consultation on the certification of quality & non-clinical data for small and medium-sized enterprises.

Regulation (EC) No 1394/2007 on advanced therapy medicinal products will apply from 30 December 2008.
Article 18 of the Regulation provides that small and medium-sized enterprises (SMEs) developing advanced therapy products may submit to the European Medicines Agency quality and, where available, non-clinical data, for scientific evaluation and certification. Provisions for the evaluation and certification of such data must be laid down by the Commission.
This public consultation document presents preliminary proposals to establish such provisions. The public consultation paper is available herepdf(28 KB)
Contributions to this public consultation should be sent by e-mail to sanco-pharmaceuticals@ec.europa.eu, before 4 July 2008.

Update 10/4/2008: Implementation of the Advanced Therapies Regulation: public consultation on the revision of Annex I to Directive 2001/83/EC.

Regulation (EC) No 1394/2007 on advanced therapy medicinal products will apply from 30 December 2008. The European Commission services have published on 13 December 2007 an implementation plan, outlining their priorities for the implementation of the Regulation. As part of this plan, the Commission intends to revise Part IV of Annex I to Directive 2001/83/EC in order to adapt it to the specificities of advanced therapy medicinal products. This public consultation document presents preliminary proposals to replace the existing Part IV of this Annex I. The public consultation paper is available herepdf(127 KB)
Contributions to this public consultation should be sent by e-mail to sanco-pharmaceuticals@ec.europa.eu, before 10 June.

Update 9.01.2008: Implementation of the Regulation on Advanced Therapies: Public call for expressions of interest as Commission appointees to the European Medicines Agency Committee for Advanced Therapies

The Commission publishes today a public call for expressions of interest relates to the appointment by the European Commission of members and alternates representing clinicians and patients' associations at the Committee for Advanced Therapies of the European Medicines Agency (EMEA). The public callpdf(234 KB) 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) is available in all EU official languages.

Expressions of interest should be notified to Nicolas Rossignol at the European Commission by e-mail to sanco-pharmaceuticals@ec.europa.eu.

The deadline for receipt of the notifications is 6.00 p.m. on Friday 14 March 2008.

Update 13.12.2007: Implementation Plan for the Regulation on Advanced Therapies

The Regulation on advanced therapy medicinal products (Regulation (EC) No 1394/2007) has been published in the Official Journal on 10/11/2007 and will apply from 30 December 2008.

Today DG Enterprise and Industry makes public its priorities for the implementation of this Regulation. The implementation plan has been developed and agreed with the European Medicines Agency (EMEA).

The joint Commission and EMA document can be found here.pdf(64 KB)

The EMA website on advanced therapies is available here.

Update 30.10.2007: Formal adoption of the Regulation on advanced therapies

On 30 October 2007, the Council has formally adopted the Regulation on advanced therapy medicinal products. All documents related to this adoption (all linguistic versions of the Regulation, results of voting, video of the Council debate etc.) are available here

Update 26.9.2007: When will the Regulation on advanced therapy medicinal products be published?

The current, provisional timeline for the formal adoption, publication and entry in application of the Regulation on advanced therapies is the following:
-On substance, the file is closed since the Council agreement on 31 May 2007 (see below);
-The Regulation now needs to be checked in all languages and formally adopted (without any discussion) by the Council. Given the average delays, this means the formal adoption by the Council will most likely occur in end October-mid November;
-The Regulation should then be published in the Official Journal, probably in end November/beginning of December. It will then enter into force 20 days after publication (i.e. most likely by the end of the year), and will apply 1 year after entry into force (i.e. most likely end of 2008).

In practice, this means that the date of entry in application for economic operators will most likely be the end of 2008.

Once formally adopted and published, the final text will be posted on this website.

Update 31.5.2007: Council approval in 1st reading

Council of Ministers approved today the Regulation on advanced therapies, in first-reading

Following the opinion of the European Parliament on 25 April, the Council of Ministers approved today the Regulation on advanced therapies, in first-reading. All Member States supported the Regulation. A first-reading agreement is therefore achieved.
An informal version of the final text, as discussed this morning in the Council, is available herepdf(29 KB) .

Next steps: the Regulation now needs to be translated in all EU official languages, checked by the linguistic revisers of the Council/European Parliament, and formally adopted, signed and published. This purely formal and administrative procedure should take a couple of months.

The Commission will start now the implementation work, together with the European Medicines Agency.

Update 25.4.2007: Vote in the European Parliament (1st reading)

On 25.4.2007, the European Parliament voted in first reading on the Commission proposal for a Regulation on advanced therapy medicinal products. The final EP opinion was adopted with a very large majority.
The adopted amendments (amendments 82 to 156) can be found herepdf(262 KB) . More information from the European Parliament, including a summary of the plenary debate, can be found here

The Press Release of the European Commission on the subject can be found herepdf(93 KB) Choose translations of the previous link Deutsch (de) français (fr) .

This 1st reading opinion of the European Parliament goes now formally to the Council of Ministers.

Update 30.1.2007:

The Environment, Public Health and Food Safety Committee of the European Parliament adopted on 30 January 2007 a report on the Commission proposal for a Regulation on advanced therapy medicinal products. The rapporteur is Dr. Miroslav Mikolášik (EPP-ED, SK) . The report, which was adopted by 55 votes to 6 with 3 abstentions, can be found herepdf(80 KB) .

The report now goes to the plenary vote of the European Parliament (so-called '1st reading opinion'). The 1st reading plenary vote is expected to take place in March 2007.

The Press Release of the European Parliament on the vote of 30.1.2007 can be found here.

Adoption of the Commission proposal on 16.11.2005:

Public Consultations:

  • DG Enterprise 2005 (closed in June 2005) consultation on a draft proposal for a Regulation on advanced therapies

Reports:

Legislation:

Others:

Advanced Therapies