Regulatory information

The regulations governing research in Europe is complex and changing. In an attempt to make keeping up with current regulations as easy as possible you will find in these pages information on EU-wide and national organisations with a remit for regulation as well as relevant documents and updates.



Disclaimer!
ESGCT has compiled this page for its members as helpful information. The European union legislation published in the paper version of the 'official Journal of the European Communities' is the only one to be deemed as official.

Advanced Therapies - Scientific Guidelines

Gene Therapy Working Party (GTWP)

  • Work Plan
  • Mandate
  • Reports

EMEA/CHMP guidance documents

  • CHMP/GTWP/587488/08 Reflection Paper Quality, non-clinical and clinical issues relating specifically to recombinat adeno-associated viral vectors (Released for consultation Mar 2009)
  • CHMP/GTWP/60436/07 Guideline on Follow-up of patients administered with gene therapy medicinal products (Released for consultation May 2008)
  • CHMP/GTWP/125491/06 Guideline on Scientific Requirements for the Environmental Risk Assessment of Gene Therapy Medicinal Products (Adopted by CHMP May 2008)
  • Overview of comments received on the above draft
  • EMEA/273974/05 Guideline on Non-Clinical testing for Inadvertent Germline transmission of Gene transmission of Gene Transfer Vectors (Adopted by CHMP November 2006)
  • Overview of comments received on the above draft
  • EMEA/CHMP/GTWP/125459/06 Non-clinical studies required before first clinical use of gene therapy medicinal products (Adopted by CHMP May 2008)
  • Overview of comments received on the above draft
  • CHMP/BWP/2458/03 CHMP Guideline on Development and Manufacture of Lentiviral Vectors
  • CPMP/BWP/3088/99 Note for Guidance on the Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products

ICH activities

  • ICH website
  • EMEA/25059/02 ICH Communication Paper on First Workshop on Gene Therapy (9 September 2002)
  • Programme, report and speakers presentations from the EMEA/ICH Workshop on Viral/Vector Shedding (30 October 2007, Rotterdam)

Cell therapy and tissue engineering

  • Guideline on Human cell-based medicinal products
  • Overview of comments received on the above draft

Cell-based Products Working Party (CPWP)

  • Work Plan 2008

EMEA/CHMP guidance documents

  • CPMP/1199/02 Points to Consider on Xenogeneic Cell Therapy Medicinal Products

Pharmacovigilance

Draft guideline on Safety and Efficacy Follow-up - Risk Management of Advanced Therapy Medicinal Products.

The guideline is released for public consultation. Please, send comments to Dr Jan Petracek at jan.petracek@emea.europa.eu by 15th August 2008.

GMP Advice

While EMEA welcomes questions on its activities and the regulatory framework within which it operates, specific questions on the interpretation of GMP requirements should be addressed, ideally by the Qualified Person, directly to the relevant supervisory authority of the Member State in which the manufacturing authorisation holder is located. Manufacturers based in third countries should contact the authority supervising the authorised importer.

Documents of interest:

  • Eudralex Volume 4: GMP Guidelines
  • Directive 2003/94/EC
  • Directive 91/412/EEC
  • Good Distribution Practice
  • Information for Qualified Persons on compliance with the requirements of the Marketing Authorisation Revision 1
  • Update on the status of revision of Chapter 5 of the GMP Guide concerning "Dedicated Facilities"
  • Community project on the practical implementation of the new obligations for manufacturing authorisation holders (Art. 46f/50f Directive 2001/83(2)/EC)
  • Update on GMP for Advanced Therapy Medicinal Products

Good Clinical Practice (GCP)

http://www.emea.europa.eu/Inspections/GCPgeneral.html

NORTH AMERICA REGULATORY AGENCY

The Center for Biologics Evaluation and Research (CBER) of the US Food and Drug Administration (FDA)

National Institutes of Health

FDA - CDER - Guidance Documents
 

The authorisation and supervision of medicinal products for human use including GMP (Good Manufacturing Practice) guidelines.

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