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Category: Pharmaceuticals & DMF

Microbial limits for non-sterile chemical drugs
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Cisema - Jacky
Thursday, 30 March 2023 / Published in News, NMPA Registration in China, Pharmaceuticals & DMF

Microbial limits for non-sterile chemical drugs, API and excipients – new guidelines issued

Microbial limits for non-sterile chemical drugs, active pharmaceutical ingredients (API) and excipients were released in
Expedited safety reporting
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Cisema - Jacky
Tuesday, 28 March 2023 / Published in News, NMPA Registration in China, Pharmaceuticals & DMF

Expedited safety reporting in drug clinical trials – new FAQ issued

Expedited safety reporting in drug clinical trials is a regulatory requirement in China that mandates
China drug standards draft measures
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Cisema - Jacky
Friday, 27 January 2023 / Published in News, NMPA Registration in China, Pharmaceuticals & DMF

China drug standards draft measures have been published by the NMPA

China drug standards draft measures have recently been released by the National Medical Products Administration
Drug Recalls in China
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Cisema - Jacky
Thursday, 29 December 2022 / Published in News, NMPA Registration in China, Pharmaceuticals & DMF

Drug recalls in China now have revised framework and focus

Drug recalls in China now designate market authorization holders (MAH) as the key responsible entity,
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  • Microbial limits for non-sterile chemical drugs

    Microbial limits for non-sterile chemical drugs, API and excipients – new guidelines issued

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  • Medical Device Supplementary Notice Period

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