Guidelines

Global guidelines for generic medicines

Last updated: 23 April 2012

The public health arm of the United Nations is World Health Organisation (WHO).

WHO provides guidelines in the area of quality assurance of pharmaceutical products. These guidelines are established and maintained through a consultative procedure and adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations. They are submitted to the WHO’s governing bodies for endorsement and subsequent implementation by Member States.

FDA issues drug shortage draft guidance

FDA announced on 21 February 2012 the release of drug shortage draft guidance for industry in order to increase the supply of critically needed cancer drugs. The announcement follows an Executive Order signed by US President Barack Obama in October 2011 in an attempt to resolve escalating shortages of life-saving medicines [1].

Interchangeability not covered in FDA draft biosimilar guidance

FDA has finally issued draft guidance documents for biosimilars. However, the guidelines still do not address the issue of interchangeability of originator drugs and biosimilars.

EMA publishes draft biosimilar guideline for interferon beta

EMA announced on 20 January 2012 that it has published a draft guideline on how pharmaceutical companies should test biosimilar medicines containing interferon beta. The draft guideline is released for a four-month public consultation period. Feedback on the draft guideline can be submitted to EMA until the end of May 2012.

Proposed biosimilars guidelines for Chile

In October 2011, Chile’s Agencia Nacional de Medicamentos (ANAMED) released draft guidance for the evaluation of biosimilars in Chile

EMA to revise overarching biosimilar guidelines

EMA announced on 17 November 2011 that it has published a concept paper asking for comments on topics to be included in a revision of the agency’s 2005 overarching guideline on similar biological medicinal products. The paper will be released for a three-month consultation period.

EU guidelines for generics

Last update: 18 November 2011

The regulatory body for approval of medicines of the EU is EMA.

When using a centralised procedure, which covers marketing authorisation for the whole of the EU, generic medicines are approved by its regulatory body, EMA.

Malaysian guidelines for biosimilars

The Ministry of Health Malaysia through the National Pharmaceutical Control Bureau (NPCB), which was set up in 1985, is the Malaysian authority that assures the quality of medicines in the country.

Malaysian guidelines for generics

The Ministry of Health Malaysia through the National Pharmaceutical Control Bureau (NPCB), which was set up in 1985, is the Malaysian authority that assures the quality of medicines in the country.

FDA hearing on biosimilars: focus on characterisation and clinical trials

A 2-day public meeting was held by the FDA on 2–3 October 2010 at Silver Spring, Maryland, USA, in order to obtain input on specific issues and challenges associated with the implementation of a biosimilars pathway as part of the BPCI Act. The discussions at the meeting focussed on the challenges associated with characterisation of such complex molecules and what clinical trials would be appropriate [1].