Access to regulatory information in Malaysia – a preliminary study

Issue title: Secrecy in Drug Regulation

Article type: Research Article

Authors: Razak, Dzulkifli Abdul

Affiliations: National Poison Centre, Universiti Sains Malaysia, 11800 Penang, Malaysia

Abstract: In 1984 Malaysia introduced legislation pertaining to drug regulatory control under The Control of Drugs and Cosmetics Regulations, 1984. A decade after its implementation, the general drug situation in the country has improved considerably and this is reflected in the number of drugs registered using the criteria of quality, safety and efficacy. However, not much attention has been paid to the question of access to regulatory information. This paper reports a preliminary survey on access to regulatory information in Malaysia, and examines the process of drug registration since the implementation of the 1984 regulations.

DOI: 10.3233/JRS-1996-9308

Journal: International Journal of Risk and Safety in Medicine, vol. 9, no. 3, pp. 179-186, 1996