Generics medicines: a tradition of quality, safety & efficacy.

About Generics

The Science of Generic Medicines

Biosimilar Medicines

Affordability & Sustainable Health

Intellectual Property

Further Resources

Generic Medicines and Science

The Science of Generic Medicines

For generic medicines, as with all other pharmaceutical products, scientifically controlled quality is of paramount importance. Generics producers seeking marketing approval in the EU must comply with stringent rules and regulations ...

EU marketing authorisation for pharmaceutical products must be applied for through the "Centralised Procedure" or the “Mutual Recognition Procedure” (MRP). A new “Decentralised Procedure” was introduced in 2005 ...

Monitoring the use and effects of a given medication to detect and prevent adverse drug reactions (ADR) is the domain of what is known as pharmacovigilance ...

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New medicinal treatments derived from biotechnology are increasingly available to healthcare markets. The downside to these new "miracle treatments" is the price of originator products ...