Singapore’s Health Sciences Authority (HSA) recently released new guidelines on the preparation of a Site Master File (SMF) for pharmaceutical Good Distribution Practice (GDP) certification. While the application for GDP certification is voluntary in Singapore, those companies that receive a certificate should... Read More
In Singapore, medical companies that plan to make a change to one of their pharmaceutical products, such as a change in labeling, packaging or manufacturing site, may submit a minor variation (MIV) application to the Center for Drug Administration under the Health... Read More
Despite the country's small size, Singapore boasts a highly-developed economy and serves as an Asian hub for numerous medical companies. In total, Singapore's medical device and pharmaceutical markets are estimated at over $800 million. Leading pharmaceutical companies, such as GlaxoSmithKline, Pfizer, Eli... Read More
In February 2005, Singapore’s Center for Drug Administration (CDA) released new guidelines on safety reporting requirements for registered medicinal products. The new guidelines apply to license holders who are responsible for bringing western medicinal products into Singapore. The guidelines define the types... Read More
Recently, the Health Sciences Authority (HSA) released new guidelines on Good Distribution Practices (GDP) for pharmaceutical materials and products in Singapore. The new guidance, effective January 1, 2005, includes new and updated information on the GDP documentation system, electronic records, EEFO (Earliest-Expiry-First-Out)... Read More
In November 2004, Singapore’s Health Sciences Authority (HSA) released new guidelines on Disease Awareness Campaigns (DACs). For companies who produce drugs for rare diseases, DACs are a convenient way for companies to educate the public about a disease and its various treatment... Read More
In June 2004, Singapore amended its Patent Bill in hopes of strengthening the country’s pharmaceutical patent system. The changes should improve the pharmaceutical sector by encouraging greater innovation and research in Singapore pharmaceutical industry. Specifically, the amended Bill focuses on improving three... Read More
In an effort to ensure that Singaporeans receive quality healthcare at reasonable prices, Singapore’s Ministry of Health introduced the Medical Service Package (MSP) on July 2, 2004. The MSP, which took effect in all public institutions on July 5, 2004, will allow... Read More
On April 20, 2004, Singapore Health Sciences Authority (HSA) released a draft Bill to amend Singapore Medicines Act. The Bill will improve Singapore standing in the medical industry through better protection of pharmaceutical patents. It will also help attract more research-based pharmaceutical... Read More
The Singaporean government plans to institute new laws by the middle of 2004 to regulate the sale of health supplements in the country. This decision was made in response to two deaths, one of a local actress, occurring in 2002 as a... Read More