RSS feedMedicines and Emerging Science
Emerging technologies
Below are guidance documents and other useful information resources relating to emerging technologies.
Phamacogenomics Working Party (PgWP)
- Work Plan 2010
- Work Plan 2009
- Mandate, objectives and rules of procedure Rev. 1
- ICH concept paper on pharmaco genomic (PG) biomarker qualification: Format and data standards
EMEA/CHMP guidance documents
- EMEA/CHMP/ICH/380636/2009
ICH E 16 Genomic biomarkers related to drug response: context, structure and format of qualification submissions
Deadline for comments September 2009 Note: The comments period has been shortened to 3 months - EMEA/151623/2009 Report on the EMEA/EFPIA Pharmacogenetics Workshop on Integrating Pharmacogenetics Early into Drug Development: PK as a working example
- CHMP/PGxWP/63270/09 Concept paper on the Development of a guideline on the use of Pharmacogenomics in the Pharmacokinetic Evaluation of medicinal products
- CPMP/1483/00 Report to CPMP on the EMEA Seminar on the Use of Pharmacogenetics in the Drug Development Process
- EMEA/CHMP/PGxWP/278789/06 Reflection Paper on the use of Genomics in Cardiovascular Clinical Trials
- EMEA/201914/06 Reflection Paper on Pharmacogenomic Samples, Testing and Data Handling
- EMEA/CHMP/536201/07 Overview of comments received on Draft Reflection Paper on pharmacogenomic samples, testing and data handling
- EMEA/128517/06 Reflection Paper on the use of Pharmacogenetics in the Pharmacokinetic Evaluation of Medicinal Products (Adopted in May 2007)
- EMEA/ CHMP/PGxWP/128435/06 Reflection Paper on Pharmacogenomic in Oncology (Released for consultation April 2008)
- EMEA/3842/04 Understanding the terminology used in pharmacogenetics
- EMEA/CHMP/PGxWP/20227/04 Guideline on Pharmacognetics Briefing Meeting (Adopted by CHMP April 2006)
International cooperation
Information about below documents can be found under Human guidelines/Multidisciplinary/Pharmacognetics
- ICH Topic E 15 Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories
- Guiding principles Processing Joint FDA EMEA Voluntary Genomic Data Submissions (VGDSs) within the framework of the Confidentiality Arrangement
- EMEA/EFPIA Workshop on Integrating Pharmacogenomics Early into Drug Development: PK as a working example
Nanotechnology is considered to be one of the emerging fields in science with great potential in a wide range of applications, including drug delivery, diagnostics and regenerative medicine. It is expected that it will contribute in developing multifunctional platforms capable of diagnosing and treating diseases.
In order to assist applicants developing nanomedicinal products, the EMEA has established a dedicated 'nano group' within the Innovation Task Force to focus on this field. The aim of the ITF nano group is to meet with applicants, discuss informally about bottlenecks in the development of nanomedicinal products, and explore possible scientific and regulatory solutions. The ITF nano group is also active in providing scientific and regulatory input on various EC initiatives and has established links with regulatory authorities in other regions.
Currently, there are no specific guidance documents on nanomedicinal products. Specific guidance on quality, toxicology, clinical development and monitoring aspects may be developed in the future, once sufficient scientific experience has been gained for specifically identified sub-technologies within the field of nanomedicines. In the absence of specific guidance, potential applicants developing nanomedicinal products are encouraged to interact with the EMEA from the early stages of development through the EMEA Innovation Task Force and/or the scientific advice procedure. See 'How to get support from the EMEA'.
- CHMP/79769/06 Reflection Paper on Nanotechnology-Based Medicinal Products for Human Use
The Agency’s think-tank group on innovative medicines development recommended that “the ongoing activities at the level of the Agency in support of the development of emerging therapies and technologies should be reinforced” as “there are particular challenges related to the introduction of these therapies [including medicines based on nanotechnology etc.] into the market”. The establishment of the adhoc expert group in 2009 and the planning of a main conference in 2010, intend to reinforce the EMEA activities in this technology area.
The Agency held the meeting of the first adhoc “nanomedicines” expert group on the 29th of April 2009. The adhoc expert group includes academic experts selected for their competences, who provide specialist input to the Working Parties on emerging new scientific knowledge and assist in the review of guidelines relevant to “nano-medicines" in order to identify any gaps and further needs.
For the executive summary of the expert meeting held in April 2009, please click here.
For the presentations given during this meeting, please click here.
Workshop on nanomedicines 26-27 April 2010
Information on EMEA activities relating to Process Analytical Technology
New manufacturing technologies
EMEA/CHMP guidance documents
- EMEA/CHMP/BWP/48316/2006 Draft guideline on the quality of biological active substances produced by stable transgene expression in higher plants (Deadline for comments 31 March 2007)
Other areas
In other areas such as therapeutic vaccines, biopharming and proteomics, final scientific guidance may not be available yet, but assistance from the EMEA may still be possible. See 'How to get support from the EMEA'.