Regulation of biologicals in Malaysia

Abstract

The regulatory oversight of biologicals in Malaysia is established by the National Pharmaceutical Control Bureau (NPCB), Ministry of Health. At the agency, the Section on Biotechnology Product Registration exercises the marketing authorization function as the National Regulatory Authority (NRA). This paper provides an overview of the organization, regulatory expectations and current practices of the evaluation of biologicals in Malaysia. Recent developments in the regulation of biologicals, focusing on biosimilars, are also presented. Because of the rapid pace of science and evolving regulatory controls, collaboration with local and international stakeholders is key to enhancing the safety and availability of biologicals/biosimilars in a cost-eff ective manner while meeting important medical needs. As resources for capacity building are not always at our disposal, we actively explore partnerships with our international counterparts who face common regulatory challenges.

An Update on the Registration of Biosimilars in Malaysia

“…The timeline for evaluation of a BTP in Malaysia has been described in a previous publication. 6 Generally, a new BTP is to be evaluated within 245 working days, excluding stop-clock for applicants to gather additional data as requested by evaluators. Although biosimilar products are evaluated as new BTPs, the evaluation timeline is generally shorter than novel BTPs (see Figure 2).…”

Regulation of biologicals in Malaysia

“…It contains a provision to align requirements with the global similar biotherapeutic product (SBP) guideline published later (in 2009) by WHO. A comprehensive discourse on this topic is discussed elsewhere [6]. To update, a total of fi ve biosimilar products have been registered by DCA as at 31 July 2014.…”