1 Introduction

Here we provide naming convention requirements for R scripts and data files. Regulatory agencies such as the FDA, EMA, and PMDA require particular naming conventions for submissions, so it is important for your project to comply with the requirements.

2 Naming conventions

All folder and file names (excluding the dot and the extension) must be lowercase and comprised of the following characters:
- Alphabetic characters from “a” to “z”
- Numbers from “0” to “9”
- Hyphen-minus “-”
No other characters (such as, underscores “_” per EMA’s file name requirements) should be used in file or folder names
Length of names of folders, datasets and other files should be:

File/folder type	Length restrictions
Folders	32 characters or less
Datasets	32 or fewer characters including the extension
Other files	64 or fewer characters including the extension
Full file path length	150 or fewer characters including the extension

2.1 Good examples

da-pk-1202.R
dv-pred-run-1003.pdf
1234.ctl

2.2 Bad examples

da-pk_1202.R
DA_J101.R
dvPREDrun-1003.pdf
dv.pred.run.1003.pdf

3 References

Following the naming conventions outlined above ensures you comply with the current guidelines of several regulatory agencies. To learn more about where these naming conventions came from, please take a look at the following resources:

FDA naming conventions are provided here with more general expectations for submitting pharmacometric data and models here and the updated 2022 population PK guidance for industry here.
PMDA naming conventions are provided here.
EMA naming conventions are provided here.