Home / Guidelines

Guidelines

FDA releases 48 new and revised bioequivalence guidelines for generics

The US Food and Drug Administration (FDA) has released 44 new draft guidance documents and four revisions to guidance documents on bioequivalence requirements for the development of generics containing 46 different active ingredients. 

FDA wants generics to be physically same as originators

Until now generics have been required to be pharmaceutically equivalent and bioequivalent to the brand-name drug, however, generics made by different manufacturers could differ substantially from their brand-name therapeutic equivalents and from each other in their physical appearance, e.g. colour, shape or size of pills. The US Food and Drug Administration (FDA), aims to change this, with guidance issued in June 2015 recommending that the physical properties, including the size, shape and colour, of generics should be similar to those of their reference drugs.

US guidelines for generics

Last update: 14 August 2015

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

Australia implements EMA’s biosimilars guidelines

The Therapeutic Goods Administration (TGA), Australia’s regulatory body for therapeutic goods, announced on 3 June 2015 that it had adopted ten European Union (EU) guidelines in Australia.

Australian guidelines for biosimilars

Last update:  7 August 2015

The regulatory body for therapeutic goods in Australia is the Therapeutic Goods Administration (TGA).

EMA opens consultation on revision of biosimilar G-CSF guideline

On 27 July 2015, the European Medicines Agency (EMA) released a draft concept paper to discuss its planned revision of its specific guideline for biosimilars containing recombinant granulocyte colony-stimulating factor (G-CSF). The draft concept paper has been released for a three-month consultation period.

EU guidelines for biosimilars

Last update: 31 July 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.

FDA outlines details of surveys into physical differences in generics

The US Food and Drug Administration (FDA) in a Federal Register notice published on 14 May 2015 has outlined how it will carry out pharmacist and patient surveys into how changes in the physical characteristics of generics pills affect patients’ perceptions.

Colombian guidelines for productos bioterapéuticos similares

Last update: 26 June 2015

The regulatory body for approval of medicines in Colombia is INVIMA – Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Colombia’s National Institute of Food and Drug Monitoring. The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Colombia.

Colombia issues further draft guidelines for biologicals

The Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social de Colombia) announced on 12 May 2015 the release of a new draft guideline on stability of biologicals in Colombia. The country also published a draft guideline on Good Manufacturing Practices (GMP) for biologicals on 17 April 2015.

Generics News Research General

more

Biosimilars News Research General

more