EC draft legislation for pharmaceutical excipients, IPEC response

26 March 2006

The European Commission is currently drawing up leg-islation covering pharmaceutical excipients and this could have "profound implications for companies that supply inactive ingredients to the drug industry," accord-ing to the Netherlands-based International Pharmaceu-tical Excipients Council (Europe). The trade organization has issued a guidance document covering Good Distri-bution Practice.

Distribution cause of public health incidents

The problem facing the excipients manufacturers is that, according to the IPEC, the majority of all major public health incidents involving the use of substandard in-active drug ingredients have come about because of problems in the distribution system and not manufacturing errors, as one might have supposed.

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