How might companies approach this issue in emerging pharmaceutical markets, such as the BRIC countries?
One area of concern in the pharmaceutical sector in these emerging countries is the tendency to wait until safety related legislation is fully in place. For interventional clinical trials, the guiding principles of GCP should be uniformly applied wherever a trial is conducted, even though there may be no legal requirement to do so. For affiliates responsible for marketed products, guiding safety principles for the ethical marketing of products should be provided, against which affiliates can be audited. This then sets global safety standards for multinational companies. Although self assessment questionnaires can be used to assess compliance, these must be underpinned by a comprehensive audit programme that enables the sharing of findings between different affiliates to enable concerted preventive action to be taken across the entire organisation. As regards the outsourcing of pharmacovigilance activities to the BRIC countries, what we have not yet heard is how quality can be ensured (
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