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Drug safety down, translation demand up

Drug safety down, translation demand upPharmaceutical companies are hurrying to setup production facilities in China. Some of them are attracted by prospects of China becoming the world's largest pharmaceutical market. Other drug companies are attracted by the chance to save costs. But all of them are heading east to take advantage of the comparatively lax regulatory system.

Nearly 80% [PDF link] of all drug substances are manufactured outside of the US. As we have seen with the contaminated heparin from China, there has been lackadaisical GMP oversight at many foreign facilities.

Unfortunately, the situation hasn't improved. BNET Pharma reported that FDA has only 2 inspectors watching drug factories in China and that the EU inspects fewer than 19 Chinese pharma factories annually.

There are real safety worries here (2008's heparin contamination was awful - just imagine what could lie ahead) but in a twist of fate, medical translators stand to reap huge rewards from this situation.

Pharma's move to China foretells huge needs for Chinese translation: With more and more pharmaceutical companies setup shop in China, there will be a huge increase in the need for Chinese versions of hiring materials, training documents, CMC and manufacturing specs, audit checklists... The list of materials to be translated goes on and on.

This puts medical translators in the uncomfortable position of benefiting financially from a broken oversight system in China that could do significant harm and even lead to more deaths. It may not be on the level of working on animal testing projects but it may still raise ethical questions among translation service providers.

2009-12-10 UPDATE: Here is an odd spin on the safety issue - FDA Dislikes Canadian Drugs; Is OK With Chinese Drugs.


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