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Research V13D05

Draft guide on monitoring medical literature released for public consultation

Home/Guidelines | Posted 13/06/2014

On 5 June 2014, the European Medicines Agency (EMA) released a draft guide on the monitoring of medical literature and the entry of relevant information into the EudraVigilance database. The draft guideline has been released for a two-month public consultation period.

Brazil flag V13C03

Brazil speeds up approval process for generics and biologicals

Home/Guidelines | Posted 06/06/2014

Brazil’s National Health Surveillance Agency [Agência Nacional de Vigilância Sanitária, ANVISA] announced on 3 June 2014 the publication of a new guideline for generics and biologicals aimed at speeding up the regulatory procedure.

Insulin 1 V13C03

EMA issues draft guideline for insulin biosimilars

Home/Guidelines | Posted 23/05/2014

On 30 April 2014 the European Medicines Agency (EMA) released a draft guideline on the non-clinical and clinical development of insulin biosimilars. The draft guideline has been released for a three-month consultation period.

Guidance V13F21

FDA releases further biosimilars guidance

Home/Guidelines | Posted 16/05/2014

The US Food and Drug Administration (FDA) has issued new draft guidance for biosimilars. The draft guideline, issued in May 2014, explains how to use clinical pharmacology data to show biosimilarity to a reference product.

Iran flag V13E31

Iranian guidelines for ‘biogenerics’

Home/Guidelines | Posted 09/05/2014

The regulatory body for approval of medicines in Iran is the Ministry of Health and Medical Education through its Food and Drug Organization (FDO). The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Iran.

Guidance V13F21

FDA releases bioequivalence guidance for 26 generics

Home/Guidelines | Posted 18/04/2014

On 2 April 2014, the US Food and Drug Administration (FDA) released 26 new draft guidance documents on the bioequivalence requirements for the development of generic drugs in question.

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Development of Iranian guidelines for ‘biogenerics’

Home/Guidelines | Posted 11/04/2014

The national regulatory authority for approval of medicines in Iran, the Iranian Food and Drug Organization (FDO), has issued its new guidelines for registration of biologicals (recombinant medicines and monoclonal antibodies) in Iran. The guideline which was published online on 15 March 2014 describes the requirements for registration of both imported and locally manufactured biopharmaceuticals into the Iranian pharmaceutical market.

EMA issues concept paper for revision of immunogenicity guideline

Home/Guidelines | Posted 28/03/2014

On 25 March 2013 the European Medicines Agency (EMA) announced the publication of a concept paper to discuss the revision of the guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins. The concept paper has been released for a three-month consultation period.

NAFDAC logo

Nigerian guidelines for biosimilars

Home/Guidelines | Posted 07/03/2014

Last update:  11 March 2014

The regulatory body for approval of medicines in Nigeria is the National Agency for Food and Drugs Administration and Control (NAFDAC). The agency, through its Regulatory and Registration Directorate, is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Nigeria.

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New Zealand guidelines for biosimilars

Home/Guidelines | Posted 28/02/2014

Last update:  28 February 2014

The regulatory body for approval of medicines in New Zealand is the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). The agency is responsible for the regulation of medicines and medical devices in New Zealand, ensuring that medicines and medical devices are acceptably safe.

TGA V13H23

Australia to adopt EMA’s monoclonal antibody guideline

Home/Guidelines | Posted 21/02/2014

The Therapeutic Goods Administration (TGA), Australia’s regulatory body for therapeutic goods, announced on 14 February 2014 that it was carrying out public consultations on the adoption of European Union guidelines in Australia.

Colombia Flag

Colombia issues draft decree for registration of biologicals

Home/Guidelines | Posted 22/03/2013

Last update:  10 January 2014

The Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social de Colombia) announced on 21 January 2013 the release of a new draft guideline for biologicals, including productos bioterapéuticos similares (similar biotherapeutic products), in Colombia.

Venezuela INHRR logo V13L06

Venezuela issues draft guideline for bioterapéuticos similares

Home/Guidelines | Posted 06/12/2013

The Venezuelan Instituto Nacional de Higiene ‘Rafael Rangel’ (INHRR National ‘Rafael Rangel’ Institute of Hygiene) via its National Monitoring Biological Products Division has released a new draft guideline for bioterapéuticos similares (similar biotherapeutics) in Venezuela.

EMA logo 1 V13C15

EMA releases product-specific bioequivalence guidelines

Home/Guidelines | Posted 22/11/2013

The European Medicines Agency (EMA) announced on 15 November 2013 the release of the agency’s first product-specific guidance on the demonstration of bioequivalence for 16 active substances. The draft guidelines have been released for a three-month public consultation period.

EMA logo 2 V13F14

EU guidelines for nanosimilars

Home/Guidelines | Posted 11/10/2013

Last update:  5 November 2013 

The regulatory body for approval of medicines in the European Union (EU) is the European Medicines Agency (EMA). The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU.

Anaemia 2 V13J18

EMA issues draft reflection paper for iron-based nano-colloidal products

Home/Guidelines | Posted 18/10/2013

On 7 October 2013, the European Medicines Agency (EMA) announced the publication of a draft reflection paper‡ to discuss the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicine. The draft reflection paper has been released for a five-month consultation period.

FDA logo V13C22

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.

EMA logo 1 V13C15

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.

Concept Paper V13G05

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.

EMA logo 2 V13F14

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.

Biologicals 2 V12K16

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.

EORTC V13C29

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.

DNA Kaku V13C15

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).