title: Multi-regional clinical trials and global drug development.
abstract: Drug development has been globalized, and multi-regional clinical trial (MRCT) for regulatory submission has widely been conducted by many discovery based global pharmaceutical companies with the objective of reducing the time lag of launch in key markets and improve patient access to new and innovative treatments. Sponsors are facing several challenges while conducting multiregional clinical trials. Challenges under the heads statistics, clinical, regulatory operational, and ethics have been discussed. Regulators in different countries such as USA, EU-Japan, and China have issued guidance documents in respect of MRCT's. Lack of harmonization in the design and planning of MRCT is perceived to create a difficult situation to sponsors adversely affecting progressing MRCT in more and more discoveries. International conference on hormonisation (ICH) has initiated the process for having a harmonized guidance document on MRCT. This document is likely to be issued in early 2017.
authors.affiliation: Quality and Regulatory, DSSPL, Bengaluru, Karnataka, India.
authors.forename: Premnath
authors.initials: P
authors.lastname: Shenoy
keywords: Clinical trials; United States of America Food and Drug Administration; international conference on harmonization; multi-regional