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FDA, global rules against fake and poor quality drugs

In the United States "products from about 150 countries are on the market, with respect to which we have a duty to assure consumers that the medicines meet both our standards and their expectations".

This is why in a globalized era we need "global rules to combat counterfeiting and quality problems of medicines".

Thus Margaret Hamburg, commissioner of the Food and Drug Administration (Fda), in a video interview released on the site of the Center for Strategic & International Studies (Csis) summarizes the perception of regulatory bodies with respect to the risks represented by the counterfeiting of medicines and the marketing of products of inadequate quality.

Globalization has revolutionized the value chain of drug research and production. Already today, a significant proportion of medicines marketed in the West are entirely produced in third countries, in many cases developing countries, or contain pharmacologically active ingredients from these areas.

Hamburg recently returned from a trip to India where she looked into the matter, in the aftermath of a series of problems encountered in the United States with medicines manufactured in this country.

Therefore, at an international level, there is an urgent need to strengthen collaboration between regulatory bodies, establishing widely shared criteria and standards that ensure ever higher quality standards.

Hamburg recounts the effort that the FDA "has made to make people understand the importance of locating its offices in different parts of the world, for example in China and India". The head of the FDA does not hesitate to indicate the close collaboration between regulatory agencies and pharmaceutical companies as the only tool capable of effectively countering the problem which, albeit in different forms, closely affects all developed countries.

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco