Drug master filing (DMF) is a relatively recent regulatory change by China’s NMPA (National Medical Products Administration) permitting active pharmaceutical ingredients (APIs), excipients and packaging materials manufacturers better protect their intellectual property and streamline market approval. The previous system was similar to that of finished drugs and was therefore very costly and time-consuming.
Process of the drug master filing (DMF)
Starting from the preparation and submission of the application dossier to the CDE (Center for Drug Evaluation), the CDE will first check the completeness of the required documents before accepting the application. Once the application is accepted, the CDE will issue the inactive DMF number, and update the status on the online platform publicly as “I”. The CDE will then move on to the “Bundle Technical Review” process and activate the filing number upon approval. The complete process of DMF filing can be expected to take around 40 weeks in total.
Note: A pre-registration number (same as the DMF number) can be obtained before the application is accepted, however, the DMF number cannot be used by the drug manufacturer until the DMF status is updated as “I”.
Support to expect from the NMPA Legal Agent
Cisema can support overseas manufacturers to obtain DMF status “I” with the following steps:
| No. | Steps |
| 1 | Prepare the registration form |
| 2 | Obtain the pre-registration number / DMF number |
| 3 | Prepare the document checklist for the application |
| 4 | Check the required documents for dossier submission |
| 5 | Translation of documents |
| 6 | Complete the application dossier |
| 7 | Submission to the NMPA |
| 8 | Obtain application acceptance with DMF status “I” and prepare for “Bundle Technical Review” |
Cisema can support overseas manufacturers with the “Bundle Technical Review” to obtain DMF status “A” with the following steps:
| No. | Steps |
| 1 | Receive and Prepare the list of supplementary documents during the Bundle Technical Review |
| 2 | Prepare supplementary documents with the customer together |
| 3 | Check documents according to the NMPA requirements |
| 4 | Dossier translation |
| 5 | Prepare final supplementary dossier |
| 6 | Submission dossier to NMPA |
| 7 | Obtain application approval with DMF status “A” |
DMF filing vs traditional registration
Before DMF was introduced in China, manufacturers could only send technical documents to individual customers / drugs manufacturers to support the registration of drugs. At present, the manufacturers can apply for their own DMF number to be used by many different drugs manufacturers in China that also allows them to have better IP protection.
NMPA Legal Agent for DMF
According to the current China NMPA (National Medical Products Administration) regulatory requirements, it is necessary to appoint an NMPA Legal Agent for DMF including the dossier submission and administrative procedures. Although the drug manufacturers can set up subsidiaries in China to take the role as their own Legal Agent or assign it to their end-product manufacturers, there are risks of over-investing or having conflict of interest for the latter.
Partnering with a well-experienced professional consulting company like Cisema has the advantages of being independent whilst using the shortest turnaround time to overcome business challenges, especially the most frequently reported problems by DMF applicants with quality standards and validation tests (batch test, safety test, long-stability test, etc.) in China.
As listed in the Q&A below, the NMPA responses to commonly asked questions by overseas manufacturers are:
Q1: Can the NMPA Legal Agent be changed?
A1: Yes.
Q2: How to change the NMPA Legal Agent?
A2: Submit a new notarized Letter of Authorization (LoA) to the NMPA.
Q3: Are there any restrictions in terms of when the NMPA Legal Agent can be changed?
A3: The NMPA Legal Agent can be changed anytime, however, the procedure must be initiated by the previous Legal Agent on the online platform for DMF filing.
By Jacky Li. Contact Cisema if you would like to learn more or receive a copy of our whitepaper on DMF in China.
