Русскоязычный заголовок: Фармацевтическая промышленность Малайзии
Фармацевтична промисловість Малайзії (англ.)
Malaysian pharmaceutical manufacturers have the capability to produce medicines in all dosage forms e.g. tablets (coated & non-coated), capsules (hard and soft gelatin), liquids, creams, ointments, sterile eye drops, small volume injectables (ampoules and vials), large volume infusions, dry powders for reconstitution and active pharmaceutical ingredients (API).
Local manufacturers have also developed and launched off-patent generics and herbal products using their own brands. Currently, the local industry is producing about 30 per cent of the domestic demand, as well as exporting to the Asia-Pacific Rim countries, the Middle East, Africa, Latin America and Europe. Total exports in 2008 amounted to RM513 million (US$142 million).
With the admission of Malaysia as a member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation/Scheme (PIC/S) in January 2002, the country's exports of pharmaceutical products received a boost, especially among the member countries, which include the EU, Australia and Canada.
The principal regulatory authority on the production, import and sale of pharmaceuticals (including traditional medicines) in Malaysia is the Drug Control Authority (DCA) of the Ministry of Health. To date, a total of 234 pharmaceutical companies with Good Manufacturing Practices certification have registered with the DCA.
Of these, a total of 67 companies are involved in the production of modern medicines comprising mainly analgesics, antacids, anti - hypertensives, diuretics, antibiotics and anti-histamines in the form of tablets, capsules, drops, powders, creams, ointments, injectibles, syrups, ophthalmic and nasal preparations. The remaining 167 companies are local traditional and herbal medicine manufacturers.
Malaysia's Intellectual Property laws conform to international standards and provide adequate protection to both local and foreign investors. The Intellectual Property Corporation of Malaysia (IPCM) was formed in March, 2003 taking over the functions of the Intellectual Property Division (IPD) of the Ministry of Domestic Trade and Consumer Affairs Malaysia, an indication of Malaysia's commitment to providing a more conducive environment for better implementation of IP rights. Malaysia is also a signatory to the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). With effect from 16 August 2006, Malaysia has acceded to the Patent Cooperation Treaty (PCT) facilitating patent registration and consequently protection to foreign inventions. The PCT permits the filing of an "international" patent application either immediately or within one year of filing of a patent application in any of the member nations.
The Clinical Research Centre (CRC) , comprising a network of 17 centers around the country, acts as the one-stop-centre by providing a single point of contact to access all Ministry of Health hospitals and clinics to conduct clinical trials in Malaysia. These clinical trial centres have linkages to more than 50 general and district hospitals, and more than 100 health clinics as potential sites for clinical trials with access to 550 clinical investigators and 17 million patients from diverse therapeutic areas in the public health care system in Malaysia.
Clinical trials services in Malaysia are also provided by the private companies such as Infokinetics Research, Clinresearch and Organon Research.
Currently, the manufacture of pharmaceuticals and related products (which include pharmaceutical goods, clinical diagnostic reagents, gelatine or gelatine products, intravenous, dialysis or irrigating solutions, vaccines, medicaments) are eligible for normal Pioneer Status or Investments Tax Allowance incentives.
The development, testing and production of pharmaceuticals promoted under biotechnology are eligible for High Technology Pioneer Status or Investments Tax Allowance incentives.