Guidelines

US guidelines for follow-on NBCDs

The regulatory body for approval of medicines in the US is the Food and Drug Administration (FDA).

FDA includes follow-on versions in its new cyclosporine guideline

In February 2016, the US Food and Drug Administration (FDA) issued a new draft guidance document for non-biological complex drugs (NBCDs). The new draft guidance on cyclosporine drug products replaces draft guidance published in March 2015.

FDA includes follow-on versions in its new liposome guideline

On 29 October 2015, the US Food and Drug Administration (FDA) issued a new draft guidance document for non-biological complex drugs (NBCDs). The new draft guidance on liposome drug products replaces draft guidance published in August 2002.

EU guidelines for follow-on NBCDs

Last update: 22 January 2016

The regulatory body for approval of medicines in the European Union (EU) is the European Medicines Agency (EMA). The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU.

EMA issues reflection paper for follow-on versions of iron-based nano-colloidal products

On 27 March 2015, the European Medicines Agency (EMA) published its reflection paper for follow-on versions of iron-based nano-colloidal products. The agency first released the draft reflection paper for follow-on versions of iron-based nano-colloidal products for a three-month consultation period in September 2013.