Guidelines

Egypt issues draft guidelines for biosimilars

Home/Guidelines | Posted 01/03/2013

The Egyptian Drug Authority (EDA) announced on 20 January 2013 that a draft guideline for the registration of biosimilars in Egypt had been released by the Central Administration for Pharmaceutical Affairs (CAPA) in coordination with the National Organization for Research & Control of Biologics (NORCB).

Draft revision of biosimilar low molecular weight heparin guideline

Home/Guidelines | Posted 08/02/2013

EMA announced on 31 January 2013 that it had released a draft guideline to revise the agency’s current guideline on biosimilars containing low molecular weight heparins (LMWHs). The draft guideline will be released for a six-month public consultation period.

China’s SFDA to fast-track high-priority generics

Home/Guidelines | Posted 01/02/2013

China’s State Food and Drug Administration (SFDA) has set out a number of proposed changes to the drug registration process, providing encouragement for domestic innovation and allowing the fast-track review of generic drugs which answer an unmet clinical need.

EMA publishes draft guideline for biosimilar human insulin

Home/Guidelines | Posted 11/01/2013

EMA announced on 14 December 2012 that it had published a draft guideline revising its current guideline on the non-clinical and clinical development of biosimilar human insulin and insulin analogues. The draft guideline will be released for a six-month public consultation period.

CESP makes submissions totally electronic

Home/Guidelines | Posted 14/12/2012

The Dutch Medicines Evaluation Board (CBG-MEB) announced on 1 November 2012 that starting from 12 November 2012, it will be possible to submit applications for marketing authorizations and deviations in the national, MRP (mutual recognition procedure) or DCP (decentralized procedure) procedures through the improved Common European Submission Platform (CESP).

China to release biosimilars guidelines

Home/Guidelines | Posted 23/11/2012

China, one of the largest pharmaceutical markets in the world, is ready to issue biosimilars guidelines.

Health Canada publishes draft GMP guideline for APIs

Home/Guidelines | Posted 09/11/2012

Health Canada announced on 22 October 2012 the publication of a draft guideline on good manufacturing practices (GMP) for active pharmaceutical ingredients (APIs).

The Common European Submission Platform

Home/Guidelines | Posted 12/10/2012

The Heads of Medicines Agencies (HMA) is currently carrying out an ‘extended proof of concept’ for the Common European Submission Platform (CESP) project aimed at establishing a single portal for electronic submissions to multiple competent authorities in the context of European registration and post-approval procedures in the European Economic Area.

EMA to accept biosimilar reference medicines from outside EEA

Home/Guidelines | Posted 05/10/2012

EMA announced on 28 September 2012 that it has adapted its guidance in order to make it easier for new biosimilar products to be approved in the EU. The changes in policy mean that EMA will accept clinical data from biosimilar medicines approved outside the European Economic Area (EEA).

India releases draft ‘similar biologic’ guidelines

Home/Guidelines | Posted 29/06/2012

India has released regulatory guidelines outlining a simple abridged procedure for evaluation of ‘similar biologics’ which have been approved and marketed in India, Europe or USA for more than four years.

Italian Medicines Agency publishes concept paper on biosimilars

Home/Guidelines | Posted 21/09/2012

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

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.

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