Clinical Trials for Medical Products in China

clinical trials in ChinaChina’s medical device and pharmaceutical markets are both among the top three largest in the world. This, along with its large population, makes China an attractive clinical research location for healthcare companies across the globe.

Pacific Bridge Medical’s China office offers comprehensive clinical trial consulting services. Our experts can manage your clinical trials in China from start to finish and ensure that the process complies with all regulatory and quality requirements. We can act as your local agent and clinical trial “sponsor” to oversee your clinical trials in China, as required by the Good Clinical Practice (GCP) guidelines released by the China Food and Drug Administration (CFDA). The CFDA is the central agency responsible for the regulation of medical devices and pharmaceuticals within China.

If you would like to learn more about the requirements and process for medical device and pharmaceutical clinical trials in China, please click on the following questions.

Clinical Trials for Medical Devices in China

Are local clinical trials required for product registration?

To determine whether local clinical trials are needed for a medical device in China, companies must first determine the classification of their device. Class I medical devices do not require local clinical trials. Class II and Class III medical devices do require clinical trials unless they have exact predicates and/or are in the CFDA’s clinical trial exemption list.

What are the requirements to obtain approval for clinical trial initiation?

Medical device clinical trials in China must comply with China’s Good Clinical Practice (GCP) requirements and should be conducted in at least two sites. Companies must follow Clinical Trials Protocol, which includes a proposal outlining the purpose and procedure of the clinical trial as well as approval from a Chinese ethics committee. Companies must also provide detailed contracts with medical institutions undertaking the clinical trials and ensure that informed consent is obtained from all participants in the clinical trial.

What are the requirements for conducting clinical trials?

Companies must complete a clinical evaluation report, which should include the collection of all clinical data obtained and the analysis and results of the data. Companies must also report any clinical risks and adverse events that occur during the clinical trials, both normal and serious (permanent injury or death), as well as suggestions for improvement and corrective actions. The report must be approved by all relevant Chinese authorities and should then be included in the product registration application.

Clinical Trials for Pharmaceuticals in China

Are local clinical trials required for product registration?

As is the case in many countries around the world, a local clinical trial is almost always required for the registration of drugs in China. Since drug registration in China follows global International Conference on Harmonisation (ICH) guidelines, data requirements in China are similar to those in the United States and other developed countries. However, companies may encounter difficulties if they want to keep sensitive data confidential from copying competitors.

In some cases, as an alternative to local clinical studies, a bioequivalence (BE) study will be required instead. The BE study will test similarities between two drugs believed to have the same active ingredients and use.

What are the requirements to obtain approval for clinical trial initiation?

The filing process for clinical trials in China begins with submitting a Clinical Trial Application (CTA) dossier to the CFDA. The Center for Drug Evaluation (CDE) reviews the submission dossier, test report, and verified specification, and requests a panel meeting if any concerns or questions are raised. The CDE may issue supplementary requests if any additional documents are needed from the applicant. The National Institute of Food and Drug Control (NIFDC) tests and analyzes the quality of the drug samples, while the Center of Food and Drug Inspection (CFDI) inspects sponsors and manufacturing sites.

After the CDE’s review, a recommendation on whether to grant the applicant a Clinical Trial Permit (CTP) is submitted for confirmation to the CFDA. The CTP approval requires an extensive length of time—about 18 months after the initial CTA dossier is submitted to the CFDA. The CFDA prioritizes which clinical trial proposals to review first according to the product’s level of importance. Drugs that aim to cure serious diseases, such as AIDS and cancer, are normally fast tracked to get clinical trial approval.

After obtaining a CTP, the company is free to initiate clinical trials at any approved site in China, as long as they follow Good Clinical Practices (GCP) throughout the clinical trials.

China_CFDA_Chart

What are the requirements for conducting clinical trials?

The CFDA’s Drug Regulatory Department oversees local clinical trials and affirms compliance with GCP. Generally, clinical trials in China involve four phases:

  • Phase I – an initial review of the drug’s safety to humans
  • Phase II – an evaluation of the effectiveness of the drug
  • Phase III – a confirmation for the effectiveness of the drug
  • Phase IV – a post-marketing study

The clinical trial’s sample size must meet statistical requirements by satisfying the minimum number of subjects outlined by the CFDA. If the institution is unable to reach the minimum sample size because of the rarity of a disease, the institution should appeal to the appropriate provincial-level FDA (PFDA) in order to reduce the sample size.

The trial must be carried out by an organization certified to conduct drug clinical trials, using drugs from manufacturing facilities that follow Good Manufacturing Practices (GMP).

If there is a serious adverse event, investigators must notify the PFDA and applicants within 24 hours, and the ethics committee thereafter. If an event is serious, the PFDA may suspend or terminate the trial. A trial may also be terminated due to fraud, ethical concerns, and failure to report adverse events.

Contact us today for a consultation on your specific needs with an expert in Chinese clinical trials and regulatory affairs.

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