New Drug Aproval

IND-Investigational New Drug, FDA-Food and Drug Administration, NDA-New Drug Application, CDER-Centre for Drug Evaluation and Research

Table 1. Comparison of Drug approval process.

Country	Time for Regulatory Approval of CTA/IND Application	Time for Evaluation of MAA	MAA Fee
Australia	120 day	50 days	$192,400
China	50 days	180 days	DNA
India	16-18 weeks	8-12 weeks	50,000 INR
UK*	35 days	210 days	£254100
USA	30 days	180 days	$217,787

*By Centralized Procedure; MAA-Marketing Authorization Application, IND-Investigational New Drug, CTA-Clinical Trial Authorization, DNA-Data Not Available.

Figure 1: New Drug Application Approval Process of FDA

Figure 2: Clinical Trial Authorization Process of EU

MAA-Marketing Authorization Application, EMEA-European Medicine Evaluation Agency, EU-European Unionion in EU

Figure 3:Centralized Procedure for Marketing Authorizat

CMS(s)-Concerned Member State(s), RMS-Reference Member State, CHMP-Committee for Human Medicinal Products

Figure 4: Decentralised Procedure for Marketing Authorization in EU

CDE-Centre for Drug Evaluation, SFDA-State Food and Drug Administration