Updated on 31 May 2012
Also, the BioNexus status awarded to qualified international and Malaysian biotechnology companies provides a number fiscal incentives, grants and other guarantees to assist growth. Since 2005, BiotechCorp has facilitated the development of 207 BioNexus-status companies in Malaysia.
Trade links with the EU and the US through the Malaysia-EU Free Trade Agreement and Trans-Pacific Partnership (TPP), respectively, can also boost the country's economic prospects and business environment. The Malaysian government has also attempted in recent years to encourage domestic manufacturers to expand production into more technologically advanced products and develop information and communications technology and other support related services.
The Medical Device Bill, Malaysia's first set of medical device regulations, was finalized in March 2008. It to yet be tabled in Parliament for approval. There is also no provision of mandatory registration for medical devices. Espicom says this is expected to change, along with the other related regulations involving production and importation of medical devices, including surveillance and monitoring.
Defining a pathway for biosimilars manufacturing, the National Pharmaceutical Control Bureau (NPCB) has adopted a guidance document and guidelines for the registration of biosimilars, making Malaysia the second country after Australia in the Asia Pacific region to adopt regulations for biosimilar registration.