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Novo Nordisk to limit use of animal testing

Danish pharmaceutical company to stop the use of living animals to test medicine quality

Novo Nordisk is to stop the use of living animals to test the quality of batches of medicines produced by the company.

The commitment has been more than ten years in the making since the establishment of a task force by Novo to get rid of redundant product control tests in living animals or to replace them with other methods of testing.

These alternatives include the use of animal cells to measure biological activity of a medicine in place of animal tests, a switch that requires regulatory approval.

Novo's case was helped by campaigning from such organisations as the European Federation of Pharmaceutical Industries and Associations (EFPIA), the trade body representing pharma companies across Europe.

Magda Chlebus, director of the EFPIA, said: “The regulatory authorities have to accept with confidence the data that we are generating to authorise products on the market. So we need to convince them that the data developed using these new tools provide as good results for the safety of patients.”

Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo, said the move was a “milestone” for the Danish pharma company.

He said: “We have been working for more than a decade, in close collaboration with regulatory authorities around the world, to eliminate obsolete tests or develop and certify new laboratory assays that can be used instead of animals to evaluate the consistent quality of our marketed products.”

The number of animals used by Novo for such product tests has been reduced over the past few years. In the 1990s, more than 13,000 animals a year were subjected to tests, but this was reduced to 772 animals a year by 2010. The final tests to be done to confirm the quality of a batch produced Novo product were for a virus treatment, performed on November 28, 2011.

However, Novo will still use animals in its research and last year used over 60,000 living animal test subjects. The company said these are “essential for all pharmaceutical companies in the processes of discovery and development of new pharmaceuticals” with authorities demanding drug candidates are tested in living animals before they can be tested in humans.

Novo produced the video below to explain the decision.

1st December 2011

From: Regulatory

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