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The agency also is continuing its efforts to join the Pharmaceutical Inspection Cooperation Scheme (PIC/S). In order to bring Taiwanese pharmaceutical companies into accordance with international standards, Taiwan's Department of Health is requiring all pharmaceutical manufacturers to comply with the standards set out in the EU's Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme. Some specific steps to be taken by the FDA include the issuance of a draft guidance on the role of quality systems in the pharmaceutical CGMP regulations, as well as seeking membership in the Pharmaceutical Inspection Cooperation Scheme, a cooperative agreement among national health regulatory authorities. |
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