Guidelines

FDA finally issues draft biosimilar guidance

Home/Guidelines | Posted 17/02/2012

The long-awaited guidance for biosimilars in the US has finally arrived. FDA announced on 10 February 2012 that it had issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the US.

Singapore guidelines for generics

Home/Guidelines | Posted 05/08/2011

Last update: 10 August 2012

Since April 2001, the Health Sciences Authority (HSA, 卫生科学局), under the authority of the Ministry of Health of the Singapore Government, has been the Singapore authority that oversees all drug manufacturing, trade, and registration.

Singapore guidelines for biosimilars

Home/Guidelines | Posted 29/07/2011

Last update: 3 August 2012

Since April 2001, the Health Sciences Authority (HSA) (Chinese: 卫生科学局), under the authority of the Ministry of Health of the Singapore Government, has been the authority that oversees all drug manufacturing, trade, and registration in Singapore.

EMA finalises pharmacovigilance guidance

Home/Guidelines | Posted 06/07/2012

EMA announced on 25 June 2012 the release of the finalised versions of seven new guideline modules outlining good pharmacovigilance practices (GVPs) to assist sponsors with complying with the soon-to-be implemented pharmacovigilance (PV) legislation, which comes into effect on 2 July 2012.

New pharmaceutical law promotes generics in Chile

Home/Guidelines | Posted 24/08/2012

In July 2012, a new pharmaceutical law was introduced in Chile. The new law aims to regulate generics bioequivalence in the country as well as enforce prescription by generic name in order to increase the use of generics.

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.