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Colombia V14I19

Concerns from EU and US over Colombian biologicals guidelines

Home/Guidelines | Posted 19/09/2014

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.

Generic V13C05

Generics group calls for say on ICH standards

Home/Guidelines | Posted 12/09/2014

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.

Conference V14A17

Generics makers comment on draft ANDA guidance

Home/Guidelines | Posted 05/09/2014

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).

DNA-Helix Serendipity V13K22

FDA releases draft guidance on reference product exclusivity for biologicals

Home/Guidelines | Posted 22/08/2014

The US Food and Drug Administration (FDA) has issued new draft guidance concerning biosimilars. The draft guidance, issued on 5 August 2014, is intended to assist sponsors in determining the date of first licensure for a reference product.

11 AA010165

FDA releases new guidance outlining generics review goals

Home/Guidelines | Posted 08/08/2014

In July 2014, the US Food and Drug Administration (FDA) issued two new draft guidance documents, which outline the agency’s goals for speeding up its handling of regulatory submissions from generics makers.

Guidance V13F21

EMA issues revised version of biosimilars quality guideline

Home/Guidelines | Posted 04/07/2014

On 26 June 2014, the European Medicines Agency (EMA) published the new version of its biosimilars quality guideline, which will revise the agency’s 2005 overarching guideline on the quality of similar biological medicinal products. The guideline will come into effect by the end of the year.

Research V13D05

Draft guide on monitoring medical literature released for public consultation

Home/Guidelines | Posted 13/06/2014

On 5 June 2014, the European Medicines Agency (EMA) released a draft guide on the monitoring of medical literature and the entry of relevant information into the EudraVigilance database. The draft guideline has been released for a two-month public consultation period.

Brazil flag V13C03

Brazil speeds up approval process for generics and biologicals

Home/Guidelines | Posted 06/06/2014

Brazil’s National Health Surveillance Agency [Agência Nacional de Vigilância Sanitária, ANVISA] announced on 3 June 2014 the publication of a new guideline for generics and biologicals aimed at speeding up the regulatory procedure.

Insulin 1 V13C03

EMA issues draft guideline for insulin biosimilars

Home/Guidelines | Posted 23/05/2014

On 30 April 2014 the European Medicines Agency (EMA) released a draft guideline on the non-clinical and clinical development of insulin biosimilars. The draft guideline has been released for a three-month consultation period.

Guidance V13F21

FDA releases further biosimilars guidance

Home/Guidelines | Posted 16/05/2014

The US Food and Drug Administration (FDA) has issued new draft guidance for biosimilars. The draft guideline, issued in May 2014, explains how to use clinical pharmacology data to show biosimilarity to a reference product.