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Italian Medicines Agency publishes concept paper on biosimilars

The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) announced on 1 August 2012 the release of a concept paper on biosimilars.

FDA finally issues draft biosimilar guidance

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 FDA announced on 10 February 2012 that it had issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the US.

Mexican guidelines for biocomparables

Last update:  25 May 2012

The regulatory body for approval of medicines in Mexico is the Federal Commission for the Protection against Sanitary Risks (COFEPRIS). The agency is a decentralised organ of the Department of Health with technical, administrative and operational autonomy, is responsible for protecting the Mexican population against sanitary risks, through sanitary regulation, control and promotion.

Singapore guidelines for generics

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

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

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

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

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

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

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.

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