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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FDA releases draft guidance on reference product exclusivity for biologicals

The US Food and Drug Administration (FDA) has issued new draft guidance concerning biosimilars. The draft guidance, issued on 5 August 2014, is intended to assist sponsors in determining the date of first licensure for a reference product.

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In July 2014, the US Food and Drug Administration (FDA) issued two new draft guidance documents, which outline the agency’s goals for speeding up its handling of regulatory submissions from generics makers.

EMA issues revised version of biosimilars quality guideline

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.

Draft guide on monitoring medical literature released for public consultation

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 speeds up approval process for generics and biologicals

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.

EMA issues draft guideline for insulin biosimilars

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.

FDA releases further biosimilars guidance

The US Food and Drug Administration (FDA) has issued new draft guidance for biosimilars.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.

Iranian guidelines for ‘biogenerics’

The regulatory body for approval of medicines in Iran is the Ministry of Health and Medical Education through its Food and Drug Organization (FDO). The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Iran.

FDA releases bioequivalence guidance for 26 generics

On 2 April 2014, the US Food and Drug Administration (FDA) released 26 new draft guidance documents on the bioequivalence requirements for the development of generic drugs in question.

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