Table 2 Drug approval timelines of the selected NMRAs

USA

6 months under priority review

10 months under standard review

180 WD

To act on 90% of the submissions within given time

To act on 90% of the submissions within given time

[33]

Australia

255 WD ^{c d}

175 WD ^{c d}

[49]

Canada

300 CD ^a

180 CD ^a

To act on 90% of the submissions within given time

To act on 90% of the submissions within given time

[50]

EU

210 WD ^c

150 WD ^c (accelerated assessment)

[51]

Japan

15.3 months

12 months ^d

9 months in the year 2013

[52]

India

180 days

120 days

[53]

Malaysia

245 WD ^{c d}

(Full evaluation)

210 WD ^{c d}

(Full evaluation)

116 WD ^{c d} (Abridge Single active ingredient)

136 WD ^{c d}(Abridge two or more active ingredients)

[2]

Singapore

180 WD ^c (abridged evaluation)

270 WD ^c (full evaluation)

60 WD ^c (for verification dossiers)

240 WD ^c (abridge evaluation)

120 WD ^c (for verification dossiers)

[30]

Republic of Korea

30 days for INDs ^e

90 days when DMF ^f review is not included

120 days when DMF ^f review is included

[28]

Sri Lanka

90 days (generic medicine)