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On 2 April 2014, the US Food and Drug Administration (FDA) released 26 new draft guidance documents on the bioequivalence requirements for the development of generic drugs in question.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

EU guidelines for biosimilars

Last update: 4 April 2014

The regulatory body for approval of medicines in the EU is EMA. The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU.

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.

Australian guidelines for biosimilars

Last update:  21 February 2014

The regulatory body for therapeutic goods in Australia is the Therapeutic Goods Administration (TGA).

Canadian guidelines for subsequent entry biologics

Last update: 11 February 2014

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.

US guidelines for generics

Last update: 7 February 2014

The regulatory body for approval of medicines in the US is the Food and Drug Administration (FDA).

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