DMF SUBMISSION IN CHINA
The Chinese regulatory agency, the National Medical Products Admininstration (hereafter referred as NMPA, formerly the SFDA or CFDA), in the past had a pre-market approval policy that allowed the drug substances / Active Pharmaceutical Ingredients (APIs), Pharmaceutical Excipients and Pharmaceutical Packaging Materials to be registered independently.
Since January 01, 2018, the NMPA has launched the Drug Master File (DMF) filing system, in which the the registration of drug substances / Active Pharmaceutical Ingredients (APIs), the registration of Pharmaceutical Excipients and the registration of Pharmaceutical Packaging Materials in China are reviewed and evaluated as part of pharmaceutical product registration submission. The new system allows the manufacturers to submit the DMFs for their own products, and to be reviewed bindingly with their customer's drug submission by referring the the particular DMF numbers.
WHO NEED TO FILE A DRUG MASTER FILE (DMF) IN CHINA
The following categories of companies who are indending to sell its products to China, should file the DMF for importation:
● Active Pharmaceutical Ingredient (API)/ Drug Substance manufacturers
● Pharmaceutical Excipient manufacturers
● Packaging Material manufacturers
DMF FILING PROCEDURE
The domestic applicant, or a local representative of an oversea applicant, should register a User Account in the DMF filing platform, and file in the application form online. Once the DMF submission dossier is prepared according to the applicable technical guidelines, submit it to the Center of Drug Evaluation (CDE) under the National Medical Products Administration for review and validation. After approval, the CDE will publish the DMF number on its official website.
The initial status of the DMF filings will be inactive (status of "I"), and once it passes the review and evaluation through bindingly review with the registration submission of a finished drug formula, the status of the DMF filings will be switched to active (status of "A").
AFTER DMF FILING
The DMF holder is required to submit an annual update, at the first quarter of every calendar year, to the CDE.
In case, there is any change to the filed information, the DMF holders owe the responsibility and obligation to notify the manufacturer of finished formula immediately. The DMF holders should take the initiaitve to investigate/study the potential impact, of change, on product quality.
When a manufacturers of finished drug formula uses the filed product in the drug formula, all the DMF holders need to do is to issue a Letter of Authorization to the manufacturers of finished drug formula, so as to refer to the filed dossier for bindingly review.
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