Medicinal products for human use

Advanced therapies - Major developments

Advanced therapies

Tissue Engineering, Cell Therapy and Gene Therapy

You will find below all information related to this Commission initiative. For any questions, please contact sante-pharmaceuticals-b5@ec.europa.eu.

02/12/2016
Summary of the responses to the targeted stakeholder consultation on the development of Guidelines on Good Manufacturing Practice for Advanced Therapy Medicinal Products pursuant to Article 5 of Regulation 1394/2007.

A summary of the responses to the targeted stakeholder consultation on the development of Guidelines on Good Manufacturing Practice for ATMPs as well as the responses can be found here.

28/06/2016
Targeted stakeholder consultation on the draft Guidelines on Good Manufacturing Practice for Advanced Therapy Medicinal Products.

  • Targeted stakeholders
    All stakeholders involved in the development, manufacture and/or commercialisation of advanced therapy medicinal products ("ATMPs"). Comments from small and medium-sized enterprises (SMEs) and academia are particularly welcome.
  • Period of consultation
    From 28 June 2016 to 26 September 2016.
  • Objective of the consultation
    Article 5 of Regulation 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC requires the Commission to draw up guidelines on good manufacturing practice specific to advanced therapy medicinal products.
    A consultation on this topic was launched in 2015. On the basis of the comments received during the consultation, as well as input from consultation with the European Medicines Agency and competent authorities in the Member States, the Commission services have developed draft Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products. With this consultation, the Directorate General for Health and Food Safety wants to give an additional opportunity for concerned stakeholders to express their views on the GMP requirements that should apply to ATMPs.
    The comments received will be taken into account by the European Commission to finalise the Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products.
  • How to submit your contribution
    Contributions should be sent before 26 September 2016 by e-mail exclusively to: SANTE-B5-ADVANCED-THERAPIES@ec.europa.eu.
    When you submit your response, please explain if you are acting as a private individual or on behalf of a company, association or other legal entity. Please state also your type of activity (e.g. R&D, manufacturing, marketing of Advanced Therapy Medicinal Products).
    If you represent a company, please state whether it falls within the EU definition of a small and medium-sized enterprise (i.e. less than €50 million annual turnover and fewer than 250 employees).
    If your organisation is registered in the Transparency Register, please indicate your Register ID number at the beginning of your contribution.
  • The consultation document
    The consultation document can be downloaded here.
  • Contact details
    Unit B5 – "Medicinal products – policy, authorisation and monitoring"
    SANTE-B5-ADVANCED-THERAPIES@ec.europa.eu
    European Commission
    DM24 02/133
    B-1049 Brussels (Belgium)
  • Privacy Statement
    Please consult the Privacy Statement to be downloaded here.

21/12/2015
Summary of the responses to the targeted stakeholder consultation on the development of Guidelines on Good Manufacturing Practice for Advanced Therapy Medicinal Products pursuant to Article 5 of Regulation 1394/2007.

A summary of the responses to the targeted stakeholder consultation on the development of Guidelines on Good Manufacturing Practice for ATMPs as well as the responses can be found here.

23/07/2015
Civil Society representatives: Call for expressions of interest is open for the EMA CAT Committee.

The deadline for submission of applications is on 30 September 2015.

23/07/2015
Targeted stakeholder consultation on the development of Good Manufacturing Practice for Advanced Therapy Medicinal Products pursuant to Article 5 of Regulation 1394/2007.

  • Targeted stakeholders
    All stakeholders involved in the development, manufacture and/or commercialisation of advanced therapy medicinal products. Comments from small and medium-sized enterprises (SMEs) are particularly welcome.
  • Period of consultation
    From 23 July 2015 to 12 November 2015.
  • Objective of the consultation
    Article 5 of Regulation 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC requires the Commission to draw up guidelines on good manufacturing practice ("GMPs") specific to advanced therapy medicinal products ("ATMPs").
    With this public consultation, the Directorate General for Health and Food Safety intends to seek the view of stakeholders regarding the GMP requirements for ATMPs.
    The comments received will be taken into account by the European Commission when developing the Guidelines on good manufacturing practice specific to ATMPs.
  • How to submit your contribution
    Contributions should be sent before 12 November 2015 by e-mail exclusively to: SANTE-D5-ADVANCED-THERAPIES@ec.europa.eu.
    When you submit your response, please explain if you are acting as a private individual or on behalf of a company, association or other legal entity. Please state also your type of activity (e.g. R&D, manufacturing, marketing of ATMPs).
    If you represent a company, please state whether it falls within the EU definition of a small and medium-sized enterprise (i.e. less than €50 million annual turnover and fewer than 250 employees).
    If your organisation is registered in the Transparency Register, please indicate your Register ID number at the beginning of your contribution.
  • The consultation document
    The consultation document can be downloaded here.
  • Contact details
    Unit D5 "Medicinal products – Authorisations, European Medicines Agency"
    SANTE-D5-ADVANCED-THERAPIES@ec.europa.eu
    European Commission
    DM24 02/133
    B-1049 Brussels (Belgium)
  • Privacy Statement
    Please consult the Privacy Statement to be downloaded here.

01/04/2014
Report on the application of the Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products.

The European Commission has adopted a Report on the application of the Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products ("ATMP Regulation") . 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.

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.

More information can be found here.

23/09/2009
Implementation of the Advanced Therapies Regulation.

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.

02/03/2009
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 here.

22/07/2008
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 here. 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.

09/07/2008
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 here.

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 here.

04/07/2008
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 here.

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

07/05/2008
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 here.

Contributions to this public consultation should be sent by e-mail to sanco-pharmaceuticals@ec.europa.eu, before 4 July 2008.

10/04/2008
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 here.

Contributions to this public consultation should be sent by e-mail to sanco-pharmaceuticals@ec.europa.eu, before 10 June.

09/01/2008
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 call  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.

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.

The EMA website on advanced therapies is available here.

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.

26/09/2007
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.

31/05/2007
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 here.

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.

25/04/2007
Vote in the European Parliament (1st reading).

On 25/04/2007, 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 here. 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 here .

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

30/01/2007
Report on the Commission proposal for a Regulation on advanced therapy medicinal products.

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 here.

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.

16/11/2005
Adoption of the Commission proposal.

Public Consultations

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

Reports

Legislation

Others

Additional information: