Home / Guidelines


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.

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.

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.

Peruvian guidelines for productos biológicos similares

Last updated: 10 January 2014

The regulatory body for approval of medicines in Peru is the Ministry of Public Health (Ministerio de Salud; MINSA).

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.

Indian guidelines for ‘similar biologics’

Last update:  29 November 2013 

The regulatory bodies responsible for approval of ‘similar biologics’ in India are the Department of Biotechnology (DBT) under the Ministry of Science and Technology through its Review Committee on Genetic Manipulation (RCGM), and the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare.

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.

Generics News Research General


Biosimilars News Research General