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  • 1.  Registration of API in China by foreign drug manufacturer (uk)

    This message was posted by a user wishing to remain anonymous
    Posted 25-Oct-2023 09:05
    This message was posted by a user wishing to remain anonymous

    Hi

    We are an API manufacturer based in the UK looking to register an API in China for use in a generic drug product. To do this we have been advised that as a prerequisite of 'a foreign generic product' this should already be approved by local/other authorities. One of the following supporting documentation should be provided:

    • Certificate of Pharmaceutical product (COPP)
    • CEP and annexes
    • Free sale certificate & manufacture license
    • FDA DMF number and approval information of related formulation by FDA

    Does anyone have any recent experience of registering an API in China (as a foreign manufacturer based outside of China)? The API in this case isn't registered by my company with any other health authority as this is for a customer specific project in China.

    Also is a manufacturing license the same as a GMP certificate? Are free sale certificates (FCS) applicable to APIs? We don't have one of these for any of our current API products, but reading around this topic these seem to be used for medical devices or for the export of products such as food, drink and agricultural products. 

    Some of the documents listed above also look to be more applicable to the 'drug product' and not the 'drug substance'.

    Any advice would be well received

    Thanks in advance



  • 2.  RE: Registration of API in China by foreign drug manufacturer (uk)

    Posted 27-Oct-2023 04:30

    Hello,

    This is what I found on the topic - https://www.gmp-compliance.org/gmp-news/china-gmp-and-registration-of-apis-q-as

    I think the key will be to find reliable local agent in China to support you with all the requirements.

    Good luck!

    Olga



    ------------------------------
    Olga Peycheva
    Regulatory and Study Start Up Specialist
    Solutions OP Ltd
    https://solutionsop.co.uk/
    United Kingdom
    ------------------------------

    Original Message


  • 3.  RE: Registration of API in China by foreign drug manufacturer (uk)

    Posted 01-Nov-2023 05:01

    To provide a clearer explanation of the regulatory requirements, we would like to specify the details more comprehensively. If an API manufacturer tends to obtain a DMF registration number in China, according to the regulations, typically one of the following combinations of certificate documents should be submitted:

    1.       API CoPP (WHO Format): Some countries issue a Certificate of a Pharmaceutical Product (COPP) for API products, such as those manufactured in the US. The FDA will issue a CoPP for API.

    2.       Free Sale Certificate (FSC) for API + API GMP documentation.

    3.       Certificate of Suitability of the European Pharmacopoeia (CEP) + relevant annexes.

    4.       Drug Master File (DMF) Number + Drug Product CoPP + API GMP (or GMP compliance report).

    5.       Free Sale Certificate (FSC) + GMP or ISO9000 (If the product is classified as food in the country of origin).

    If none of the above combinations of prerequisites can be provided, you can explore the possibility of the following solutions:

    1.     Replace the Free Sale Certificate with any document that can demonstrate that your product is permitted to be sold on the market, even if it is approved for export only.

    2.     If the API is exclusively supplied to specific drug companies and the drug product that uses this API has been approved in the countries out of China, you can attempt to provide a declaration to explain the situation to replace the DMF No. or FSC.

    3.     If you are unable to provide any certificates, an alternative solution is to submit the API documents together with the drug product dossier when applying for registration. The API documents can be sent to the China Drug Evaluation (CDE) separately and independently without disclosing them to the drug applicant. In this case, the API would not be granted a DMF registration number, but it could still be used in drugs marketed in China.

    Please be aware that for options 1 and 2, as they do not represent the typical means of demonstrating the marketing authorization eligibility of an API product, we strongly recommend engaging in communication with the CDE before proceeding with the submission of documents intended for certificate replacement.

    For any further questions or details, please feel free to contact me at raymond@accestra.com or info@accestra.com – you may also learn more on the following website: www.dmfchina.com If could provide more information about the project background, we would be happy to provide further advise.



    ------------------------------
    Raymond Ng
    China Regulatory Affairs
    Accestra Consulting
    China Regulatory Outsourcing for Food & Drug for NMPA/CFDA registration of China Drug: NDA/IND/DMF/APIs www.accestra.com
    Contact: Info@accestra.com
    ------------------------------

    Original Message


  • 4.  RE: Registration of API in China by foreign drug manufacturer (uk)

    Posted 06-Nov-2023 11:17
    Edited by Hamish King 06-Nov-2023 11:18

    Dear Anonymous 

    Yes, we are familiar with registering API from non-Chinese manufacturers into China. 

    It is still possible in principle to register your API in China even if it is not registered with any other health authority. 

    And yes, a manufacturing license is same as GMP certificate. 

    Free sales certificates (FSC) are applicable to APIs too.  

    It seems there are a lot of uncertainties. For API registration in China, we would generally recommend firstly a GAP analysis to review and close the deficiencies with your current documentation.

    Please feel free to email me in case of more questions at hamish.king@cisema.com. 

    Regards

    Hamish



    ------------------------------
    Hamish King
    hamish.king@cisema.com
    www.cisema.com
    ------------------------------

    Original Message


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