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Chinese guidelines for biosimilars

Last update:  21 November 2014

Since 2003, the China Food and Drug Administration (CFDA) (simplified Chinese: 国家食品药品监督管理局) is the Chinese authority that oversees all drug manufacturing, trade, and registration.

China releases draft biosimilars guidance

On 29 October 2014 China’s Center for Drug Evaluation (CDE) published draft guidance for approval of biosimilars.

EU guidelines for biosimilars

Last update: 7 November 2014

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 revised version of overarching biosimilars guideline

On 29 October 2014, the European Medicines Agency (EMA) published the new version of its overarching biosimilars guideline, which will revise the agency’s 2005 overarching guideline on similar biological medicinal products.

Concerns from EU and US over Colombian biologicals guidelines

On 21 January 2013, the Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social de Colombia) released a new draft guideline for biologicals, including 'productos bioterapéuticos similares' (similar biotherapeutic products), in Colombia [1]. Since then, both the European Union (EU) and the US have expressed concerns over the draft guidelines.

Generics group calls for say on ICH standards

The generics industry is somewhat annoyed at being excluded from the decision-making process of a global organization, which harmonizes drug quality, safety and efficacy standards.

Generics makers comment on draft ANDA guidance

The quality of abbreviated new drug application (ANDA) submissions could be improved if the US Food and Drug Administration (FDA) spent more time with generics companies before they file an application, according to the Generic Pharmaceutical Association (GPhA).

FDA releases draft guidance on reference product exclusivity for biologicals

The US Food and Drug Administration (FDA) has issued new draft guidance concerning biosimilars. The draft guidance, issued on 5 August 2014, is intended to assist sponsors in determining the date of first licensure for a reference product.

US guidelines for biosimilars

Last update: 22 August 2014

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

FDA releases new guidance outlining generics review goals

In July 2014, the US Food and Drug Administration (FDA) issued two new draft guidance documents, which outline the agency’s goals for speeding up its handling of regulatory submissions from generics makers.

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