I. Introduction

1. Regulatory Background

Drug Administration Law of the People's Republic of China, Regulations for Implementation of the Drug Administration Law, Provision for Drug Registration.

2. The period of validity of Drug Product License

Drug Product License is valid for five years dated from NMPA issuance. To continue its drug production or importation, the applicant shall submit a renewal application six months prior to the expiry date.

3. Applicant Qualification

A domestic applicant shall be an institution legally registered within the territory of People's Republic of China that independently assumes civil liability and an overseas applicant shall be a legal overseas drug manufacturer or marketing authorization holder.

4.  Classification of Drugs

Traditional Chinese medicines and natural medicines; chemical medicines; biological products.

5. Authorities

Acceptance and Evaluation: Center for Drug Evaluation of NMPA (CDE)

Approval and Certificate Issuance: National Medical Products Administration (NMPA, former CFDA)

II. Drug Registration Target

Beijing Canny Consulting Inc. offers professional consulting services for drug registration in China and helps applicants obtain Approval of Investigational New Drug Application or Drug Product License.

III. Content of Services

1. Act as a local agent for drug registration.

2. Perform feasibility evaluation and gap analysis to evaluate risks, avoiding failure in registration due to the non-compliance with regulatory requirements and policies.

3. Provide an outline for application dossier.

4. Review, translation, improvement, compilation and submission of CTD-format application dossier.

5. Submission, tracking and reply to questions for sample testing.

6. Track registration progress, reply to questions raised by authority: compile and submit supplementary documents.

7. Receiving the Product License

IV. New Drug Application (NDA) Procedure

1. IND application

Pre-submission meeting → IND submission → Accepted by CDE → Technical review (60 working days) → Approval of IND

2. NDA application

Completion of clinical trial/ Bridging of overseas clinical trial data → NDA submission → Accepted by CDE → Technical review → Administrative approval → Drug Product License

Remark: Overseas GMP inspection may be required during technical review.

3. Generic Drug Application Procedure

Remark: Overseas GMP inspection may be required during technical review.