IAPO Americas

Useful links

There are many other helpful websites and resources about biological and biosimilar medicines.




International Drugs Regulatory Agencies


European Medicines Agency - EMA

The European Medicines Agency (EMA) was the first regulatory body in constructing guidelines (2005).

In September 2010, the European Commission launched the Process on Corporate Responsibility in the Field of Pharmaceuticals focusing on, amongst others areas, non-regulatory conditions for better access to medicines. An information paper was published, including a specific Question & Answer part targeting patients, physicians and payers (in English, Spanish and Portuguese). The European Medicines Agency contributed to the paper within their responsibilities and competence.


World Health Organization - WHO

In 2009, the World Health Organization published a Guidelines on Evaluation of Similar Biotherapeutics Products (SBP), to provide guidance to National Regulatory Authorities (NRA) for the development and the evaluation of the products, helping in the harmonization of the requirements worldwide.

The International Conference of Drug Regulatory Authorities (ICDRAs) provide drug regulatory authorities of WHO Member States with a forum to meet and discuss ways to strengthen collaboration. The 16th International Conference of Drug Regulatory Authorities (ICDRA) was held in Rio de Janeiro, Brazil - 24-29 August 2014. Recommendations are proposed for action among agencies, WHO and related institutions.


Food and Drug Administration - FDA

In 2012, the US Food and Drug Adminstration (FDA) issued a draft guidance for the industry.


For more information about international regulation, see Research


Regional Agencies and Working Groups


The Biotechnological Products Working Group (WG Bio) - Pan American Health Organization (PAHO).

Mission: Promote the development of the regulation of biotechnological products in the countries of the Americas Region, and to generate more effective and harmonized mechanisms for the regulation of this category of medicines.

Languages: English and Spanish.


National Medicines Regulatory Authorities


WHO issued a list of globally identified websites of medicines regulatory authorities.


Publication and research centres


Generics and Biosimilars Initiative - GaBi

Mission: The mission of GaBI is to foster the worldwide efficient use of high quality and safe medicines at an affordable price, thus advancing and supporting the idea of accessible, affordable and sustainable health care. GaBI aims to raise the scientific status of generic and biosimilar medicines, and to provide comprehensive, high quality, scientifically sound, reliable, well-documented and up-to-date information about generic and biosimilar medicines both in print and electronically in an open access format.