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FDA calls for comment on generics user fees guidelines

The US Food and Drug Administration (FDA) announced in a Federal register publication of 6 February 2015 the reopening of the docket to solicit public comment on certain topics related to implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) and the GDUFA Commitment Letter that accompanies the legislation.

FDA calls for comment on biosimilars interchangeability

The US Food and Drug Administration (FDA) wants drugmakers to comment on the information requirements for biosimilars interchangeability.

FDA releases 53 new and revised bioequivalence guidelines for generics

On 12 December 2014, the US Food and Drug Administration (FDA) released 31 new draft guidance documents and 22 revisions to guidance documents on bioequivalence requirements for the development of generics containing 42 different active ingredients.

Australia reviewing plans for naming biosimilars

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), has changed its plans for naming biosimilars, ‘following recent international developments in the area of biosimilar naming’.

EU guidelines for biosimilars

Last update: 23 January 2015

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 guideline on non-clinical and clinical issues for biosimilars

On 18 December 2014, the European Medicines Agency (EMA) published the new version of its guideline addressing the non-clinical and clinical issues related to similar biological products (biosimilars) containing biotechnology-derived proteins as the active substance. This new guideline will revise the agency’s 2006 overarching guideline on the non-clinical and clinical issues related to similar biological medicinal products.

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.

FDA to carry out survey into affect of generics shape, colour, size

The US Food and Drug Administration (FDA) wants to understand how patients’ perceptions of medications change when pharmacies switch from brand-name to generic drugs or between the same generics made by different manufacturers and how this affects patient adherence to their medication.

US guidelines for generics

Last update: 28 November 2014

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

China releases draft biosimilars guidance

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

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