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Global guidelines for generic medicines Guidelines | Posted 20/10/2010

Last updated: 23 April 2012The public health arm of the United Nations is World Health Organisation (WHO).WHO provides guidelines in the area of quality assurance of pharmaceutical products. These...

Are generic medicines too expensive in Europe? Reports | Posted 20/10/2010

Professor Steven Simoens speaks to GaBI Online about this and other issues surrounding generics.

WHO prequalification programme for medicines Policies & Legislation | Posted 20/10/2010

Today, one third of the world’s population lacks access to essential medicines. In the poorest parts of Africa and Asia this figure rises to a half of the population.

Canadian guidelines for generics Guidelines | Posted 20/10/2010

Last update: 3 August 2012 The regulatory body for approval of medicines in Canada is the Therapeutic Products Directorate of Health Canada.Health Canada develops and enforces regulations unde...

Delays in FDA approval of biosimilar G-CSF (filgrastim) Biosimilars/News | Posted 20/10/2010

Teva Pharmaceutical Industries announced on 30 September 2010 that the FDA has requested additional information for the Biologic License Application (BLA) for Neutroval (filgrastim), its biosimilar...

Tentative approval for more new Sun Pharma generics Generics/General | Posted 20/10/2010

Sun Pharma is not slowing down with the number of new generic medication introductions. The latest generics to come out of the company include versions of riluzole hydrochloride and rosuvastatin.

Sun Pharma finally wins battle for Taro Pharma News | Posted 08/10/2010

On 21 September 2010 India-based generics manufacturer Sun Pharmaceutical Industries (Sun Pharma) announced that it had acquired a controlling stake in Israel generics’ firm Taro Pharmaceuticals In...

Australia approves first biosimilar filgrastim Biosimilars/News | Posted 08/10/2010

On 26 September 2010 US-based generics manufacturer Hospira announced that it had received approval from the Therapeutic Goods Administration (Australia's regulatory agency for medical drugs and de...