Guide on Pharmaceutical Industy in Malaysia
Published by：Malaysian Investment Development Authority
Number of Pages：49
This guidebook for the pharmaceutical industry in Malaysia serves as an important source of information for investors intending to invest in this industry. It also spells out the procedures and requirements for the various applications for licences and permits for the setting up of a business in the pharmaceutical industry.
Table of Content
Fact Sheet of Malaysia
In this topic, the background of Malaysia and key Economic Indicator is listed in details.
・Background of Malaysia
・Key Economic Indicator
Healthcare in Malaysia
Malaysia’s primary care model has been acknowledged by the World Health Organisation as a viable system to achieve “Health for All”.
・The Pharmaceutical Industry in Malaysia
・Intellectual Property (IP) Protection
Getting Started in Malaysia
For starting a business in Malaysia, the main fees which need to be paid are fees to the Companies Commission of Malaysia (SSM) and fees for company secretarial services.
・Starting a business
・Approval of Manufacturing Projects
・Approval of Expatriates Posts
Incentives for Investment
The manufacturer of pharmaceuticals and related product is categorised as “promoted activities” or “promoted products”.
・Incentives for Manufacturing Companies
・Incentives for High Technology Companies
・Incentives for Strategic Projects
・Incentives for Research & Development (R&D)
・Automation Capital Allowance Expenditure (ACA)
・Incentives for the Principal Hub
Regulatory Control in the Pharmaceutical Industry
In this topic, Regulatory Agency, Drug control agency, Product registration, New application processing procedure, Application formalities, Application processes, Regulatory outcome, Registration maintenance, Online registration system, License issued for registered products, are lsited in details.
・Drug Control Authority
・New Application Processing Procedures
・Online Registration System
・Licence Issued for Registered Products
・Manufacturing Licence Application Procedures
・Bioavailability and Bioequivalence Study for Pharmaceutical Products
In this topic, MIDA Overseas offices and MIDA state offices are listed in details.
・MIDA Overseas Offices
・MIDA State Offices