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

Drug Approval Process In USA

The Food and Drug Administration (FDA) is responsible for protecting and promoting public health. Like general drug approval process, FDA’s new drug approval process is also accomplished in two phases: clinical trials (CT) and new drug application (NDA) approval. FDA approval process begins only after submission of investigational new drug (IND) application. The IND application should provide high quality preclinical data to justify the testing of the drug in humans. Almost 85% of drugs are subjected to clinical trials, for which IND applications are filed. The next step is phase I clinical trials (1-3 years) on human subjects (~100). The drug’s safety profile and pharmacokinetics of drug are focused in this phase. Phase II trials (2 years) are performed if the drug successfully passes phase I. To evaluate dosage, broad efficacy and additional safety in people (~300) are the main objective of the phase II. If evidence of effectiveness is shown in phase II, phase III studies (3-4 years) begins. These phase III concerns more about safety and effectiveness of drug from data of different populations, dosages and its combination with other drugs in several hundred to about 3,000 peoples. A new drug application (NDA) can be filed only when the drug successfully passes all three phases of clinical trials and includes all animal and human data, data analyses, pharmacokinetics of drug and its manufacturing and proposed labelling. The preclinical, clinical reports and risk-benefit analysis (product’s beneficial effects outweigh its possible harmful effects) are reviewed at the Center for Drug Evaluation and Research by a team of scientists. Generally approval of an NDA is granted within two years (on an average), however, this process can be completed from two months to several years. The innovating company is allowed to market the drug after the approval of an NDA and is considered to be in Phase IV trials. In this phase, new areas, uses or new populations, long-term effects, and how participants respond to different dosages are explored. Figure 1 represents the new drug approval process of FDA.