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FDA publishes guidance on ANDAs for new strengths

Home/Guidelines | Posted 25/10/2013

The US Food and Drug Administration (FDA) has published draft guidance for industry for abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) where the applicant is seeking approval of a new strength of the drug product.

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EMA organizes workshop on biosimilars guidelines

Home/Guidelines | Posted 27/09/2013

The European Medicines Agency (EMA) announced on 25 September 2013 that the agency would be organizing a workshop on biosimilars.

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EMA issues draft concept paper on comparing quality in biologicals and biosimilars

Home/Guidelines | Posted 05/07/2013

On 28 June 2013, the European Medicines Agency (EMA) released a draft concept paper to discuss the issue of how to compare the quality attributes for biological products and biosimilars. The draft concept paper has been released for a three-month consultation period.

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Revision of guideline on clinical and non-clinical issues for biosimilars

Home/Guidelines | Posted 14/06/2013

On 10 June 2013, EMA released a revision of the guideline addressing the clinical and non-clinical issues related to similar biological products (biosimilars) containing biotechnology-derived proteins as the active substance. The draft guideline has been released for a six-month consultation period.

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EMA issues draft revision of overarching biosimilar guidelines

Home/Guidelines | Posted 10/05/2013

EMA announced on 2 May 2013 the publication of its new draft biosimilars guideline, which will revise the agency’s 2005 overarching guideline on similar biological medicinal products. The draft guideline has been released for a six-month consultation period.

FDA logo V13C22

FDA issues draft guidance for biosimilar meetings

Home/Guidelines | Posted 05/04/2013

FDA announced on 1 April 2013 that it had issued draft guidance for biosimilar meetings outlining standardized procedures for requesting, preparing, scheduling, conducting and documenting such formal meetings with FDA.

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Guideline update on prevention of febrile neutropenia with G-CSF

Home/Guidelines | Posted 29/03/2013

Patients undergoing chemotherapy for cancer are at risk of developing the sometimes fatal condition of febrile neutropenia (FN), involving infection, fever and sepsis due to a loss of neutrophils. Prophylaxis with recombinant granulocyte colony-stimulating factor (G-CSF) has been shown to reduce hospital admissions, antibiotic use and the need for chemotherapy dose reduction. Several forms of recombinant G-CSF are available, including filgrastim and its biosimilars, or the pegylated version of filgrastim. All three are considered to be equivalent in terms of clinical efficacy and safety.

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EMA releases guidelines on biosimilar interferon beta and r-FSH

Home/Guidelines | Posted 15/03/2013

In March 2013, EMA released two guidelines on how pharmaceutical companies should test biosimilar medicines containing interferon beta and recombinant follicle stimulation hormone (r-FSH).

EDA

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).

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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.

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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.

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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.

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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).

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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.

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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).

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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.

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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).

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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.