The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use)
is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from
the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
The purpose is to make recommendations on ways to achieve greater harmonisation in the interpretation and application of
technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing
carried out during the research and development of new medicines.
GCP (Good Clinical Practice)
The European Medicines Agency is a decentralised body of the European Union, located in London. Its main responsibility
is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human
and veterinary use.
European Public Assessment Reports
(EPARs) Once a medicine has been granted a Community marketing authorisation by
the European Commission, the European Medicines Agency publishes a full scientific assessment report called a
European Public Assessment Report (EPAR). Here you will find key information
for a medicine including a Q&A on
the medicine and the patient leaflet.
The Food and Drug Administration is responsible for protecting the public health by assuring the safety,
efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply,
cosmetics, and products that emit radiation.
The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and
foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information
they need to use medicines and foods to improve their health.
allows you to search for official information about FDA approved brandname and generic drugs and
therapeutic biological products.
The World Health Organisation is the directing and coordinating authority for health within the United Nations system.
It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms
and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and
assessing health trends.
Specific Health Topics:
Joint UN Programme on HIV/AIDS is an innovative partnership that leads and inspires the world in
achieving universal access to HIV prevention, treatment, care and support.
works to change lives by sharing information about HIV and AIDS. We believe independent,
clear and accurate information is vital in the fight against HIV and AIDS.