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The Indian national government last month approved the creation of an autonomous unit to regulate the import, licensing, quality and safety of pharmaceutical and medical device products.
The Taiwanese Department of Health's Bureau of Pharmaceutical Affairs (BPA) has developed new rules on pharmaceutical preparations, source materials, processes, quality control, safety and efficacy involving genetically altered drugs.
Two companies announced they are taking steps to provide easier access to needed medications in developing countries, while an advocacy group claimed a third company is preventing access to HIV medication through an overload of patents.
A little more than week after Ranbaxy Laboratories launched generic Lipitor in Denmark, Pfizer won a preliminary injunction blocking its sale, a Pfizer spokesman said.
Generic drug firms operating in the European Union (EU) should work closely with state agencies to mitigate drug approval delays caused by bureaucratic overload, the European Generic medicines Association (EGA) said at an industry conference last week.
Sponsors beginning clinical trials in France before May 1, 2004, were advised to follow the French Huriet Law of Dec. 20, 1988, as amended, for the protection of persons involved in biomedical research.
The UK’s National Health Service’s (NHS) drug price regulation scheme should be changed to a value-based system that focuses more on patients and providing better benefits, an Office of Fair Trading (OFT) report recommended.