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Table 2 Drug approval timelines of the selected NMRAs

From: Regulatory requirements for the registration of generic medicines and format of drug dossiers: procedures in Sri Lanka in comparison with selected regulatory authorities

Jurisdiction Legislated drug approval time Targeted drug approval time Achieved drug approval time Reference
NDA g or NCE h ANDA i or generic medicines NDA or NCE h ANDA i or generic medicines ANDA i or generic medicines  
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)  
  1. a CD Calendar dates
  2. b The performance goal for the year 2010 was to act 90% of this given timeline
  3. c Working days
  4. d including client time
  5. e Investigational New Drug
  6. f DMF: Drug Master File
  7. g NDA- New Drug Application
  8. h NCE- New Chemical Entity
  9. i ANDA – Abbreviated New Drug Application