Guidelines

FDA agrees to meet GAO demands on revised guidance for complex generics

Home/Guidelines | Posted 09/02/2018

The US Government Accountability Office (GAO) released a report on 16 January 2018, in which it stated that the US Food and Drug Administration (FDA) should release plans to issue or revise guidance for complex generic drugs. FDA made an official response in which it laid out its plans for the future which address many of the GAO's concerns.

China FDA issues draft guidance on drug review and approval transparency

Home/Guidelines | Posted 02/02/2018

China Food and Drug Administration (CFDA) announced on 16 January 2018 that it had issued draft guidance on the public disclosure of information related to its review and approval of drug applications.

EMA regulatory guidance update to prepare for Brexit

Home/Guidelines | Posted 26/01/2018

In preparation for the UK’s withdrawal from the European Union (EU), set to take place on 29 March 2019, the European Medicines Agency (EMA) and the European Commission have issued regulatory guidance to pharmaceutical companies. The EU wants to ensure that pharmaceutical companies plan for Brexit to avoid any impact on the continuous supply of medicines within the EU.

FDA updates its list of drugs without generics

Home/Guidelines | Posted 12/01/2018

The US Food and Drug Administration (FDA) announced in December 2017 that it had updated its list of drugs without generics.

FDA guidance aims to encourage abuse-deterrent generic opioids

Home/Guidelines | Posted 05/01/2018

The US Food and Drug Administration (FDA) has issued new guidance intended to encourage generics makers to make abuse-deterrent formulations of opioids.

Australian guidelines for biosimilars

Home/Guidelines | Posted 10/06/2011

Last update: 5 January 2018

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

Indian guidelines for ‘similar biologics’

Home/Guidelines | Posted 07/12/2012

Last update: 5 January 2018

The regulatory bodies responsible for approval of ‘similar biologics’ in India are the Department of Biotechnology (DBT) under the Ministry of Science and Technology through its Review Committee on Genetic Manipulation (RCGM), and the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare.

Stakeholders comment on FDA’s draft statistical biosimilarity guidance

Home/Guidelines | Posted 08/12/2017

The US Food and Drug Administration (FDA) released draft guidance on statistical approaches to evaluate similarity for biosimilars in September 2017 [1]. Comments from stakeholders on the guidance indicate that they want it to be more specific and narrower in scope.

FDA publishes new draft guidance for ADHD generic

Home/Guidelines | Posted 24/11/2017

In October 2017, the US Food and Drug Administration (FDA) issued new product-specific draft guidance for generic methylphenidate oral extended-release tablets.

India updates its similar biologics guidelines

Home/Guidelines | Posted 10/11/2017

The Indian Ministry of Health has revised its guidelines for approving ‘similar biologics’. The guideline was updated in order to make the regulatory pathway more robust and to align the guidelines further with global guidelines for biosimilars. The update was seen as essential in order to meet the ‘ever changing global standards’.