Guidelines

FDA issues updated guidance on implementing GDUFA II

Home/Guidelines | Posted 13/12/2019

The US Food and Drug Administration (FDA) has revised and replaced its draft guidance on implementing the Generic Drug User Fee Amendments of 2017 (GDUFA II).

Health Canada publishes biosimilars fact sheet

Home/Guidelines | Posted 06/12/2019

Health Canada has published a fact sheet on biosimilars, which aims to provide a comprehensive overview on a number of issues concerning biosimilars.

FDA issues draft guidance for insulin biosimilars

Home/Guidelines | Posted 29/11/2019

The US Food and Drug Administration (FDA) announced on 25 November 2019 that it had issued draft guidance on immunogenicity considerations for insulin biosimilars.

EC publishes biosimilar information for healthcare professionals in 23 languages

Home/Guidelines | Posted 08/11/2019

The European Commission (EC) and the European Medicines Agency (EMA) have published an information guide on biosimilars aimed at healthcare professionals in 23 languages.

FDA issues final guidance on petitions delaying generics

Home/Guidelines | Posted 08/11/2019

The US Food and Drug Administration (FDA) announced on 18 September 2019 that it had issued final guidance to address ‘gaming’ by the use of citizen petitions.

US guidelines for biosimilars

Home/Guidelines | Posted 12/11/2010

Last update: 25 October 2019

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

FDA planning more guidance for developers of complex generics

Home/Guidelines | Posted 18/10/2019

As part of its efforts to advance the development of generics of complex drugs with the aim of improving patient access to medicines, the US Food and Drug Administration (FDA) announced that it is planning to release new and revised guidance documents for complex generics.

EMA provides guidance on avoiding nitrosamines in human medicines

Home/Guidelines | Posted 11/10/2019

On 26 September 2019, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) provided guidance on avoiding the presence of nitrosamine impurities in human medicines containing chemically synthesized active substances, following a request from EMA’s Executive Director. 

FDA organizes workshop on complex generics

Home/Guidelines | Posted 13/09/2019

The US Food and Drug Administration (FDA) has announced that the agency is organizing a workshop on the regulation of complex generics.

Comments on FDA’s plans to transition insulin products

Home/Guidelines | Posted 14/06/2019

The US Food and Drug Administration (FDA) held a public meeting on the 13 May 2019 to discuss access to affordable insulin products and issues related to the development and approval of biosimilar and interchangeable insulin products.