Guidelines

Canadian guidelines for generics

Home/Guidelines | Posted 20/10/2010

Last update: 3 August 2012

The regulatory body for approval of medicines in Canada is the Therapeutic Products Directorate of Health Canada.

Health Canada develops and enforces regulations under Canadian governmental legislation.

EMA finalises biosimilar monoclonal antibody guidelines

Home/Guidelines | Posted 22/06/2012

EMA announced on 15 June 2012 that it had finalised two guidance documents describing how pharmaceutical companies should develop biosimilar monoclonal antibodies. The guidelines set out how developers should conduct extensive side-by-side analysis of the test and reference products in order to determine similarities and potential differences between the biosimilar and reference biological.

Guidelines for substitution of generics in The Netherlands

Home/Guidelines | Posted 18/06/2012

Marketed medicines that have passed bioequivalence testing should in general be substitutable. The Royal Dutch Pharmacists Association (KNMP) has published professional guidelines for community pharmacies concerning generics substitution. The generics substitution guidelines are based on scientific principles and provide a strong impetus for maintaining uniform professional standards.

EMA revised guideline on quality of biosimilar medicines open for comments

Home/Guidelines | Posted 08/06/2012

EMA announced on 31 May 2012 that it had released a revised guideline for public consultation describing how pharmaceutical companies should address the quality aspects of biosimilar medicines.

Mexican biocomparables guidelines come into force

Home/Guidelines | Posted 18/05/2012

The Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) announced on 20 April 2012 that the Mexican guidelines for biocomparables had come into force.

Turkish guidelines for generics

Home/Guidelines | Posted 04/05/2012

Last update: 4 May 2012

The regulatory body for approval of pharmaceutical products in Turkey is the General Directorate of Pharmaceuticals and Pharmacy (GDPP).

EMA released pharmacovigilance guidelines for public consultation

Home/Guidelines | Posted 30/03/2012

EMA has released its first batch of guidelines on good pharmacovigilance practices (GVP) for public consultation until 18 April 2012.

Australian government urged not to make further cuts to PBS

Home/Guidelines | Posted 23/04/2012

In the wake of historically the largest single price cuts to prescription medicines in Australia, both Medicines Australia and the Generic Medicines Industry Association of Australia (GMiA) are urging the government that further cuts to the Pharmaceutical Benefits Scheme (PBS) are not justified.

Global guidelines for generic medicines

Home/Guidelines | Posted 20/10/2010

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

Home/Guidelines | Posted 02/03/2012

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

Home/Guidelines | Posted 17/02/2012

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

Home/Guidelines | Posted 27/01/2012

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

Home/Guidelines | Posted 20/01/2012

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

Home/Guidelines | Posted 09/12/2011

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

Home/Guidelines | Posted 08/10/2010

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

Home/Guidelines | Posted 05/08/2011

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

Home/Guidelines | Posted 29/07/2011

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

Home/Guidelines | Posted 08/07/2011

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].

Australian guidelines for generics

Home/Guidelines | Posted 24/06/2011

Last update: 1 July 2011

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

Japanese guidelines for generics