Table 4.
Regional Initiatives Working to Clarify Specific Points to Consider for Oligonucleotide Therapeutics
| Regional initiatives | Activities |
|---|---|
| US-based OSWGa | White papers (published [6–12]) |
| Japanese WGS6 | White papers (published in Japanese [13] and summarized in this review) |
| Local guidelines (PSEHB/PED Notification No. 330-1) [65] | |
| EFPIA | Survey on regulatory trends [14] |
| EU | Reflection paper on genotoxicity (issued [15]) |
a
OSWG, a subcommittee of the DIA (Drug Information Association, Inc.).
EFPIA, European Federation of Pharmaceutical Industries and Associations; OSWG, Oligo Safety Working Group; WGS6, Japanese Research Working Group for the ICH S6 and Related Issues.