How long would it normally take to introduce or register new pharmaceutical products in Malaysia?
A 7: The client charter of the National Pharmaceutical Control Bureau of Malaysia indicates a period of 17.5 months to process such an application. However, if documentation is complete during application, the process takes 9-12 months. The rules and regulations for imports and exports have been published, and information on the registration procedures is already available to the public. In addition, the ASEAN Consultative Committee for Standards and Quality (ACCSQ) has established a product working group on pharmaceuticals to develop harmonisation schemes of pharmaceutical regulations of the ASEAN member countries without compromising on drug quality, efficacy and safety. The work programme of this working group includes the development of common technical requirements for pharmaceutical product registration for ASEAN and the development of common technical dossier for Pharmaceutical Product Registration for ASEAN with a view of arriving at MRAs. The targeted timeframe is up to year 2
A 7: The client charter of the National Pharmaceutical Control Bureau of Malaysia indicates a period of 17.5 months to process such an application. However, if documentation is complete during application, the process takes 9-12 months. The rules and regulations for imports and exports have been published, and information on the registration procedures is already available to the public. In addition, the ASEAN Consultative Committee for Standards and Quality (ACCSQ) has established a product working group on pharmaceuticals to develop harmonisation schemes of pharmaceutical regulations of the ASEAN member countries without compromising on drug quality, efficacy and safety. The work programme of this working group includes the development of common technical requirements for pharmaceutical product registration for ASEAN and the development of common technical dossier for Pharmaceutical Product Registration for ASEAN with a view of arriving at MRAs. The targeted timeframe is up to year 2
