In China, drugs are classified into traditional Chinese medicine (TCM for short), chemicals and biological products. Registrants of active pharmaceutical ingredients (APIs for short) and pharmaceutical packaging materials need to register and submit relevant materials on the Center for Drug Evaluation, NMPA (CDE for short). 

      APIs and packaging materials that pass formal review after its registration in platform will get a registration number of “I”. If the product passes technical review when it is associated with preparation review, the status of the registration number will change from “I” to “A”. After obtaining the registration number, CDE will publicize its basic information such as the registration number, product name, enterprise name and production address.

      Domestic manufacturers, as registrants, shall register their own products by themselves.

      Overseas manufacturers shall entrust a Chinese Legal Agent for registration.

Registration-related Laws and Regulations Are Based on:

  • Drug Administration Law of the People’s Republic of China,
  • Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China,
  • Measures for the Administration of Drug Registration,
  • Announcement of the General Administration on the Adjustment of the Review and Approval of APIs, Pharmaceutical Excipients and Pharmaceutical Packaging Materials (No. 146 of 2017),
  • Announcement of the National Medical Products Administration on Further Improving the Review, Approval and Regulation of Drug Associations (No. 56 of 2019), etc.

Drug Consulting Service

      HMK services for several pharmaceutical companies to provide them with China marketing approvals, drug master filing (DMF), China good manufacturing practice (GMP), gap analysis, CMC consulting, other quality and regulatory services, as well as China Legal Agent service.

Services
Review the application materials, conduct difference analysis and pre-check the quality information;

Provide guidance on the evaluation requirements to improve the quality of application materials
Translate and proofread foreign application materials
Preparation, arrangement and submission of application materials;

Provide or assist in writing supporting document templates if necessary
Timely follow up the progress of CDE review
Assist in responding to supplementary information in the process of technical review, and prepare and submit supplementary information
Customs clearance, transportation and storage of samples for registration and inspection;

Sample delivery, follow-up of inspection supervision and problem reply
Maintenance of changes in the contents of registration materials (including major changes, medium changes, minor changes and basic information changes)
Submission of annual reports

Process of AEP Registration, Review and Approval

      AEP is the abbreviation of APIs, pharmaceutical excipients, packaging materials and containers in direct contact with pharmaceuticals.  

      The following chart is a brief introduction to the declaration process for chemical drug biological products. Please contact HMK for more information.

Drug

Contact Us

      Please contact us if you or your company is faced with the following concerns:

  • You are a pharmaceutical company that has received a supplementary notice from NMPA and is preparing the second technical evaluation document.
  • You want to mail test samples to China laboratory, but do not know how to complete customs clearance.
  • You are not sure about the testing items required in China.
  • You cannot find a satisfied testing organization.
  • You would like to know the registration cycle in China.
  • You would like to know the types of documents to be submitted in China.
  • You would like to obtain some information related to drug market in China.
  • You do not know how to determine the NMPA legal agent.
  • You are not sure whether the ingredients of your product meet Chinese standards.
  • You are worried that you cannot communicate smoothly with NMPA due to language and cultural differences, geographical restrictions and other factors, resulting in product registration failure.
  • You are a pharmaceutical packaging or ingredient manufacturer and need to obtain drug master filing (DMF) information in China.
  • You would like to translate Chinese regulatory standards into Japanese or English.

Service Process

Step 1  Send Us Your Needs

You can contact us at any time by filling out an inquiry form, sending an email or calling.

Step 2  Confirm Your Needs

Upon receipt of your request, we will communicate with you about your specific requirements. If necessary, we will sign a confidentiality agreement.

Step 3  Make a Service Plan

We will make a service plan according to STEP 2. If necessary, we will communicate further by face-to-face meeting, emails, or calling.

Step 4  Sign an Agreement

We will sign an entrustment agreement.

Step 5  Start Our Project

We will begin to work according to our agreed details.

Step 6  Report Progress

We will report the project progress regularly.