Guidelines

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.

Venezuela issues draft guideline for bioterapéuticos similares

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 releases product-specific bioequivalence guidelines

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.

EU guidelines for nanosimilars

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.

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

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 publishes guidance on ANDAs for new strengths

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 organizes workshop on biosimilars guidelines

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