From June 2003, registrations of new pharmaceutical products in Malaysia can be done online. The Malaysian government, through the National Pharmaceutical Control Bureau (NPCB) has established a comprehensive online registration system which allows manufacturers, license holders, and resellers of pharmaceutical products to conduct registrations, product change requests, market sampling, renewals, and other transactions online. The online transactions are conducted through the NPCBâ€™s secure Quest 2 Online Submission System.
The NPCB is currently conducting training classes to help users familiarize themselves with the features of the Quest 2 system. Classes are conducted until October 24, 2003 and interested parties can sign up for the training courses online at www.bpfk.gov.my/training/pharma/training_pharma.asp.
The full features of the Quest 2 system have yet to be fully implemented. Registration for new chemical entities (NCEs) and biotech products will not begin online until January 2004 and renewals and amendments will likely begin in the fourth quarter of 2003.