| Year |
|
Document/Guidance |
| 2002 |
EMEA/CPMP/3070/01 |
Position paper on Terminology |
| 2006 |
CHMP/PGxWP/20227/04 |
PGt Briefing meetings |
| 2007 |
EMA/128517/06 |
RP on Use of PGt in PK evaluation |
| 2007 |
|
Voluntary Genomic Data Submission |
| 2007 |
EMEA/CHMP/../2001914/06 |
RP on PGX samples, testing and data handling |
| 2007 |
ICH- E-15
CHMP/ICH/437986/06 |
Definitions of Genomic BMs, PGt, PGx & genomic data |
| 2008 |
CHMP/PGxWP/128435/06 |
RP on PGx in oncology |
| 2012 |
EMA/CHMP/37646/09 |
Use of PGt methodologies in PK evaluation of Med Products |
| 2011 |
EMA/CHMP/446337/11 |
RP on Methodological issues and patient selection |
| 2012 |
EMA/CHMP/917570/11 |
PGX methods in Pharmacovigilance evaluation of medicinal products. |
These guidelines and reflection papers were issued from the Pharmacogenomic
Working party ( PGWP)of CHMP in consultation with ICH and other agencies.