REGULATORY BODIES IN CHINA
National Medical Products Administration (NMPA)
Main regulatory body in China which handles pharmaceutical drug registration management, look after formulating and organizing drug registration, review them and approve or reject them accordingly.
Drug Evaluation Center (CDE)
Under NMPA, Reviewing the clinical trials of drugs, applications for drug marketing authorization, any supplementary applications and applications for re-registration are done by CDE.
Chinese Food and Drug Administration (CFDA/CNDA)
It is responsible for safety and management of food, medical devices, health products, cosmetics and drug in the region. It is directly under the state council.
CLASSIFICATION OF DRUGS IN CHINA
As per Pharmaceutical Regulations in China, NMPA classifies drugs into 3 categories and on the basis of these categories the products are developed or registered, those categories are-
1. Chemical Drugs - 6 classes (NCE Related -2)
2. Biological Drugs - 15 classes
3. Traditional Chinese medicines – 9 Classes
They are also classified into 5 categories for drug application as-
1. Improved new drugs
2. Innovative drugs
3. Import drugs
4. Generic drug (Original Drug approved in China)
5. Domestic generic drug (Original drug not approved in China)
There are 2 registration path-way for foreign manufacturers includes improved new/innovative drug or imported drugs and 2 clinical strategies includes parallel development and sequential development.
All the foreign drugs that belongs outside China are requires to register as DMFs via Imported Drug application.
For New drug applications (NDA) NMPA has initiated 4 programs for accelerating the review and approval of drug which includes-
a) Conditional approval (CA)
b) Breakthrough therapy designation (BTD)
c) Priority review (PR)
d) Special approval (SA)
NMPA and its institutions offers technology and policy support which includes communication, technical guidance allocation of resources and decreasing the review time to the applicant if NDA enters any of these categories.
For the registration of generic product for importers or overseas manufacturers without legal representation needs to apply for product registration through agent services. The application is submitted to CFDA after which CDE runs through review process of the product.
DOCUMENTS REQUIRED FOR DRUG REGISTRATION IN CHINA
Dossier shall be directory as per the “Provisions of Drug registration” for application items.
Document with the information: Name of application item or drug/product, item number, applicant name, address and contact number.
Import License (Import drug registration application form)
Import quota certificate (wherever applicable)
Inspection or Clinical testing certificate (where applicable)]
Quality and safety license
APPLICATION FOR CLINICAL TRIAL
Application for clinical trial is submitted
CDE carry out the test report and overall documentation review which takes about 40-60 days depending on the product.
The review report is further sent to CFDA with the recommendation by deciding that the product should opt for clinical trial or bioequivalence study.
If it opt for clinical study it can be divided into 4 phases
If applicant receives clinical trial or bioequivalence study approval, the applicant is free to choose the hospitals for conducting clinical trials from the given clinical trial hospitals list and all the study should be carried out in compliance with GCP (Goods Clinical Practice).
After the successful completion of clinical study, Manufacturer/ applicant gets the approval document along with the consent form and study reports which forms the documents required for the drug registration application.
SFDA Evaluation center will evaluate and review the information. If it passes, the file is passed for final approval and provides Pharmaceutical registration certificate which is valid for 5 Years.
IMPORT DRUG REGISTRATION PROCESS as per Pharmaceutical Regulations in China
Applicant submits the clinical study report and other document along with import drug registration form;
CFDA/SFDA review evaluate and send notification if any additional information required;
SFDA CDE evaluation takes about 120 days and if additional document requires then takes about 160 days;
CDE review the drug in about 40-50 days and send report to SFDA/CFDA;
SFDA/CFDA approval takes about 20-30 days. And the Import registration certificate is provided to the applicant or manufacturer/importer.
TIMELINE FOR DRUG REGISTRATION
It takes about 8-9 months or 270- 350 days for full registration process which includes 30-35 days after the submission of application for notification, 80-90 days for evaluation of clinical trials, 30-40 days for approval by NMPA, 120-150 days for evaluation of drug by CDE and again 30-40 days to get the approval from NMPA after clinical trials.
Approval from the US/EU could fast-track the approval in China
China's National Medical Products Administration (NMPA) does consider approvals from well-regulated international agencies like the FDA and EMA as part of the evaluation process. This is because the FDA and EMA have rigorous and comprehensive regulatory standards for drug approval. Therefore, if a drug has been approved by these agencies, it can provide valuable data and evidence supporting the drug's safety, efficacy, and quality.
However, the NMPA still requires the applicant to provide additional data and information specific to the Chinese population and regulatory requirements. This includes data from Chinese clinical trials, safety and efficacy data in Chinese patients, and other relevant documentation.
The NMPA's approval process for foreign drugs typically involves the following steps:
Acceptance and Evaluation: The applicant submits the required data and documentation to the NMPA for evaluation. This includes data from foreign clinical trials and regulatory approvals.
Bridging Studies: In some cases, the NMPA may request "bridging studies," which are additional clinical trials or studies conducted in Chinese patients to confirm the safety and efficacy of the drug in the Chinese population.
Technical Review: The NMPA conducts a technical review of the submitted data to ensure compliance with Chinese regulatory requirements and standards.
On-Site Inspection: Depending on the product and other factors, the NMPA may conduct on-site inspections of the manufacturing facilities.
Approval Decision: Based on the evaluation and review process, the NMPA makes a decision on whether to approve the drug for marketing in China.
Having approvals from reputable international agencies like the FDA or EMA can streamline the Chinese approval process as it provides a foundation of prior evaluation and a certain level of confidence in the drug's safety and efficacy. However, it's important to note that the NMPA's approval process may still have its own unique requirements and considerations specific to the Chinese market.
Drug Application Fees
Post Marketing Surveillance
The NMPA has established a robust pharmacovigilance system to gather, analyze, and evaluate data related to adverse drug reactions. This system enables the detection of any potential safety signals or emerging risks associated with drugs. The National Adverse Drug Reaction Monitoring Information Network serves as a key component of the pharmacovigilance system and plays a crucial role in monitoring and evaluating the safety of pharmaceutical products available in the Chinese market.
Risk Assessment and Evaluation: The NMPA conducts risk assessments and evaluations based on the reported adverse drug reactions and other safety data. This process helps in determining the severity and frequency of ADRs and in making decisions on the safety profiles of drugs.
Artixio can help you obtain the marketing authorization for pharmaceutical products in China using our regional teams. Please get in touch with us today for any assistance needed in China.