towards worldwide harmonisation of drug approval

VIEWS & REVIEWS Towards worldwide hannonisation of drug approval By 1995, the International Conference on Harmonisation (ICH) is expected to produce uniform guidelines for drug registration in the 3 largest markets. Thus, America, Europe and Japan are working together to this end. Major topics of discussion by the ICH include the demonstration of efficacy, safety and quality of new drugs, and the process of communication between regulatory authorities and applicant companies. Even if the guidelines produced by the ICH are not binding in character, it is expected that they will provide the pharmaceutical industry with useful directions and proposals. The ICH was used at the European Course in Pharmaceutical Medicine [13 Oct 1994; Basel, Switzerland] as an example of how the 'strict approach' of the US FDA has contributed to setting the standard for pharmaceutical medicine, including the harmonisation of worldwide drug approval. - Media release Adi. International Limited 1994. All rights reserved 5 INPHARMA- 5 Nov 1994

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Page 1: Towards worldwide harmonisation of drug approval

VIEWS & REVIEWS

Towards worldwide hannonisation of drug approval

By 1995, the International Conference on Harmonisation (ICH) is expected to produce uniform guidelines for drug registration in the 3 largest markets. Thus, America, Europe and Japan are working together to this end.

Major topics of discussion by the ICH include the demonstration of efficacy, safety and quality of new drugs, and the process of communication between regulatory authorities and applicant companies. Even if the guidelines produced by the ICH are not binding in character, it is expected that they will provide the pharmaceutical industry with useful directions and proposals.

The ICH was used at the European Course in Pharmaceutical Medicine [13 Oct 1994; Basel, Switzerland] as an example of how the 'strict approach' of the US FDA has contributed to setting the standard for pharmaceutical medicine, including the harmonisation of worldwide drug approval. - Media release

INPHARMA- 5 Nov 1994

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