Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Per China "Specification for Procedures and Technical Requirements of Drug Registration Testing (Trial Version)":  The samples for registration testing should be manufactured on a commercial scale, and the key information of the origin and the primary packaging materials in direct contact with drugs should be consistent with those provided when applying for marketing authorization. 

Does this requirement extend to the drug substance used to manufacture the China registration testing samples? Do you have successful experience of conducting China registration testing samples with finished products manufactured at the commercial DP site, but with drug substance from a non-commercial site or scale?

Thanks,

RAPS member

Hi, Anon,

Regarding the marketing authorization of drug product in China, usually NIFDC will only request for the sample testing of DP, otherwise the manufacturer also want to market the drug substance individually. So if NIFDC also request you the samples of drug substance now? Please free feel to contact me and share us more information so that we can see if we can help you.

Best regards.

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Jennie Yang
RA Director
Heaslicen Pharma Consulting
www.heaslicen.com
HeaslicenPharma@163.com
Beijing, China
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Original Message:
Sent: 26-Apr-2024 08:43
From: Anonymous Member
Subject: China registration testing samples

This message was posted by a user wishing to remain anonymous

Per China "Specification for Procedures and Technical Requirements of Drug Registration Testing (Trial Version)":  The samples for registration testing should be manufactured on a commercial scale, and the key information of the origin and the primary packaging materials in direct contact with drugs should be consistent with those provided when applying for marketing authorization. 

Does this requirement extend to the drug substance used to manufacture the China registration testing samples? Do you have successful experience of conducting China registration testing samples with finished products manufactured at the commercial DP site, but with drug substance from a non-commercial site or scale?

Thanks,

RAPS member

Jennie is more of an expert than I, but I will just add that this has been my experience as well. NIFDC is only concerned with testing DP. However, they may insist that certain tests that are usually only part of the DS specification (specifically for biotech drugs) be included b/c they are in the CP. While they certainly should pass, this has caused some consternation among my Analytical colleagues since we've never actually performed the test on the DP.

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Rachel Thornton
Director
Smyrna GA
United States
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Original Message:
Sent: 26-Apr-2024 08:43
From: Anonymous Member
Subject: China registration testing samples

This message was posted by a user wishing to remain anonymous

Per China "Specification for Procedures and Technical Requirements of Drug Registration Testing (Trial Version)":  The samples for registration testing should be manufactured on a commercial scale, and the key information of the origin and the primary packaging materials in direct contact with drugs should be consistent with those provided when applying for marketing authorization. 

Does this requirement extend to the drug substance used to manufacture the China registration testing samples? Do you have successful experience of conducting China registration testing samples with finished products manufactured at the commercial DP site, but with drug substance from a non-commercial site or scale?

Thanks,

RAPS member