EBE Comments
- 30-09-11 EBE Comments on Concept Paper for Biosimilars Containing Recombinant Insulin
- EBE Comments on Concept Paper for Biosimilars Containing Recombinant Insulin - Sept11
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- 30-09-11 EBE Comments on Concept Paper for Biosimilars Containing Low-Molecular Weight Heparins
- EBE Comments on Concept Paper for Biosimilars Containing Low-Molecular Weight Heparins
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- 31-05-11 EBE Comments on EMA GL on Biosimilars Containing mAbs
- EBE Comments on Biosimilars Containing mAbs - May11
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- 31-05-11 EBE Comments on EMA GL on Immunogenicity Assessment of mAbs
- EBE Comments on GL on Immunogenicity Assessment of mAbs - May11
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- 31-05-11 EBE Comments on Concept Paper on Biosimilars Containing Biotech-Derived Proteins as Active Substance
- EBE Comments on Biosimilars Containing Biotech-Derived Proteins - May11
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- 25-05-11 EFPIA-EBE Response to Commission Green Paper on Research and Innovation Funding
- EFPIA-EBE Response to European Commission Green Paper on Research and Innovation Funding
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- 08-03-11 EBE-EFPIA Comments on Q&A on Post Approval Change Management Protocols
- EBE-EFPIA Comments on Q&A on Post Approval Change Management Protocols
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- 28-01-11 EBE Response to Commission Consultation on European Innovation Partnership on Active&Healthy Ageing
- 31-12-10 Joint EuropaBio-EBE Submission to the FDA on Biosimilars
- 28-10-10 EBE Comments on Procedural Advice on the Consultation of Notified Bodies
- EBE Comments on Procedural Advice on the Consultation of Notified Bodies - Oct10
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- 15-09-10 EBE Response to EC Consultation on Revision of IVD Directive
- EBE Response - Revision of IVD Directive - Sept10
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- 30-06-10 EBE Comments on Reflection Paper on Stem Cell-based Medicinal Products
- EBE Comments on Reflection Paper on Stem Cell-based Medicinal Products - June2010
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- 04-05-10 EBE Comments on EMA Road Map to 2015
- EBE Comments - EMA Road Map to 2015
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- 19-01-10 EBE Comments on the Assessment of the Clinical Trials Directive
EBE submitted comments highlighting the impact of the Directive on SMEs, and in particular those developing orphan medicines.
- EBE Comments on CTD - Jan10
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- 24-07-09 EBE-EuropaBio Comments on COMP Recommendation on Significant Benefit for Orphan Designation
EBE - EuropaBio comments on draft COMP Recommendation on elements required to support the medical plausibility and the assumption of significant benefit for an orphan designation.
- E-EuropaBio Comments - Significant Benef for Orphan Designation
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- 16-03-09 EFPIA-EBE-EVM Position on Animal Welfare
Review of Directive 86/609 on the protection of laboratory animals.
EFPIA-EBE-EVM ask to strike the right balance between animal protection, medical research and patients' needs.
- Animal Welfare EFPIA-EBE-EVM
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- 12-10-07 EBE Response to EC Consultation on the Future of Pharmaceuticals in Europe
The European Commission DG Enterprise and Industry has just closed a 3-month public consultation on the “Future of pharmaceuticals in Europe” in order to make Europe a hub for safe and innovative medicines. EBE participated in the consultation on behalf of the European biopharmaceutical industry sector and made specific recommendations for improving the regulatory framework.
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- 17-08-07 EBE Comments on EMEA Draft Guideline on Comparability
- EBE Comments to EMEA draft GL on Comparability of Biotech Medicines after Manufacturing change, 27 April 2007
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- 17-08-07 EBE comments on guideline Human Cell-Based Medicinal Products
- EBE comments on Guideline on Human Cell-Based Medicinal Products, 31 July 2007
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- 01-08-07 EBE comments on the EMEA Guideline Immunogenicity Assessment of Biotech-Derived Therapeutic Proteins
- EBE comments on the EMEA Guideline Immunogenicity Assessment of Biotech-Derived Therapeutic Proteins
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- 25-05-07 EBE comments on Guideline on the requirements for First-in-Man CT for potential high-risk Medicines
- EBE Comments on Guideline First-in-Man CT
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- 24-04-07 Advanced Therapies Regulation request to MEPs
Brussels, 23 April 2007
EFPIA & EBE ask MEPs to make a swift adoption of the Advanced Therapies Regulation possible by supporting the new-cross party package
This will allow a first reading adoption of this urgently needed Regulation
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- Voting Proposal for Advanced Therapies EP vote of 25 April 2007
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- 30-03-07 EBE Comments on draft EMEA Guideline on Conditional Marketing Authorisation
- EBE comments on EMEA draft Guideline on Conditional Marketing Authorisation, 30 March 2007
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- 28-03-07 EBE-EFPIA Position Paper on Biosimilars Labelling, 28 March 2007
- EBE-EFPIA Paper on Biosimilars Labelling, 28 March 2007
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- 29-09-06 EBE submission on the Life Sciences & Biotechnology Strategy mid-term review
- EBE submission on the Life Sciences & Biotechnology Strategy mid-term review, 29 Sept 2006
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- 30-06-06 EBE Submission on Bio4EU Study
- EBE Submission on Bio4EU Study, 30 June 2006
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- 31-05-06 EBE comments on EMEA concept paper on Guideline on Immunogenicity Assessment of Therapeutic Proteins
Comments on the EMEA/CHMP/BMWP/246511/2005
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Concept Paper on Guideline on Immunogenicity Assessment
of Therapeutic Proteins (EMEA/CHMP/BMWP/246511/2005)
EBE and EuropaBio members welcome the EMEA initiative in developing a Concept Paper for the release of a Guideline on Immunogenicity Assessment of Therapeutic Proteins.
- EBE comments on EMEA concept paper on Guideline on Immunogenicity Assessment of Therapeutic Proteins, 31 May 2006
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- 31-05-06 EBE-EuropaBio comments on the EMEA concept paper on Guideline on Comparability of Biotechnology...
Comments on the EMEA/CHMP/BMWP/9437/2006
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Concept Paper on Guideline on Comparability of Biotechnology-Derived Medicinal Products after a change in the Manufacturing Process - Non-Clinical and Clinical Issues
- EBE-EuropaBio comments on the EMEA concept paper on Guideline on Comparability of Biotech Medicines after a manufacturing change, 31 May 2006
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- 24-11-05 EBE Comments to the EMEA Q&A on the new Scientific Advice and Protocol Assistance Procedure
Comments on the framework for scientific advice & protocol assistance (EMEA/267187/2005)
In September 2005 the EMEA launched a set of questions and answers describing an improved procedure for Scientific Advice and Protocol Assistance for public consultation.
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- EBE Comments to the EMEA Q&A on the new Scientific Advice and Protocol Assistance Procedure, November 2005
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- 31-10-05 EBE Comments to the EMEA draft Operational Procedure on handling consultation with target patients
EBE Comments to the EMEA draft Operational Procedure on handling "consultation with target patient groups" on Package Leaflet for Centrally Authorised products for human use (EMEA/277378/2005)
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- EBE Comments to the EMEA draft Operational Procedure on handling consultation with target patients, October 2005
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- 30-09-05 EBE Comments to the EMEA draft Guideline on Clinical Trials in Small Populations
EBE Comments on the EMEA Guideline on Clinical Trials in Small Populations (CHMP/EWP/83561/2005)
In March 2005 the EMEA Committee for Medicinal Products for Human Use (CHMP) issued a Guideline on Clinical Trials in Small Populations.
EBE, the Emerging Biopharmaceutical Enterprises representing more than 65 biopharmaceutical companies in Europe welcomes the EMEA’s initiative to consult interested parties in the creation of guidance to facilitate clinical trials for which there are few patients available.
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- EBE Comments to the EMEA draft Guideline on Clinical Trials in Small Populations, 30 September 2005
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