Home / Guidelines

Guidelines

EMA issues draft guideline for insulin biosimilars

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.

FDA releases further biosimilars guidance

The US Food and Drug Administration (FDA) has issued new draft guidance for biosimilars.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.

Iranian guidelines for ‘biogenerics’

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.

FDA releases bioequivalence guidance for 26 generics

On 2 April 2014, the US Food and Drug Administration (FDA) released 26 new draft guidance documents on the bioequivalence requirements for the development of generic drugs in question.

Development of Iranian guidelines for ‘biogenerics’

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

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.

Nigerian guidelines for biosimilars

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.

New Zealand guidelines for biosimilars

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.

Australia to adopt EMA’s monoclonal antibody guideline

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 issues draft decree for registration of biologicals

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.