Guidelines

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.

EMA revised guideline on quality of biosimilar medicines open for comments

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

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

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

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

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.