Navigating China’s Drug Approval Process: Key Steps for Success

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The process of getting a new drug approved in China can be complex and time-consuming. It involves multiple stages of testing and review by regulatory agencies to ensure the drug’s safety and efficacy.

In this article, we’ll provide a comprehensive guide to China’s drug approval process, including an overview of the regulatory agency, preclinical studies, clinical trials, NMPA review, and post-market surveillance.

China’s Drug Regulatory Agency

The National Medical Products Administration (NMPA) is China’s regulatory agency responsible for the approval of drugs, medical devices, and cosmetics. The NMPA was established in 2018, merging the China Food and Drug Administration (CFDA) and other related agencies. The NMPA has a significant role in ensuring the safety, efficacy, and quality of drugs sold in China.

Moreover, it implements strict regulations to ensure that all drugs meet the same standards as those set by the World Health Organization (WHO). The agency establishes stringent safety and efficacy requirements for drug approval.

Preclinical Studies

Before a new drug can be tested in humans, it must undergo preclinical studies to evaluate its safety and efficacy. In China, preclinical studies must be conducted in compliance with Good Laboratory Practice (GLP) guidelines. These studies include pharmacological and toxicological testing and are required for the new drug application process in China.

Pharmacological testing involves studying the drug’s mechanism of action and its effects on biological systems. Toxicological testing involves evaluating the drug’s potential toxicity to living organisms. The results of these studies are included in the new drug application package submitted to the NMPA.

Clinical Trials

Clinical trials are conducted to evaluate the safety and efficacy of the new drug in humans. In China, the clinical trial process consists of three phases.

  1. Phase 1 involves a small group of healthy volunteers to evaluate the drug’s safety and dosing.
  2. Phase 2 includes a larger group of patients to evaluate the drug’s efficacy and side effects.
  3. Phase 3 involves a larger patient population to confirm the drug’s efficacy and monitor any adverse events.

The clinical trial data must be submitted to the NMPA in the new drug application (NDA) package. The data must follow Good Clinical Practice (GCP) guidelines and include detailed information on the trial design, patient demographics, adverse events, and efficacy outcomes.

NMPA Review

The NMPA review process is a critical step in the drug approval process in China. The process consists of three stages, each of which plays an important role in ensuring the safety and efficacy of drugs sold in China. Here are the three stages of the NMPA review process:

Technical Review

The technical review is the first stage of the NMPA review process.

In this process, they evaluate the new drug application package submitted by the drug manufacturer to ensure it meets all regulatory requirements. This can be checking that the preclinical data and clinical trial data meet the required standards, and that the drug’s manufacturing process meets Good Manufacturing Practice (GMP) guidelines.

If the application package meets all regulatory requirements, the NMPA will proceed to the next stage of the review process. If there are any issues with the application package, the NMPA will request additional information or clarification from the drug manufacturer.

Onsite Inspection

During this stage, the NMPA conducts an inspection of the drug manufacturing facility to ensure compliance with GMP guidelines. The inspection involves a review of the manufacturing process, quality control systems, and documentation procedures.

The NMPA may also inspect the clinical trial sites to ensure compliance with Good Clinical Practice (GCP) guidelines.

If the onsite inspection identifies any issues, the NMPA will request corrective action from the drug manufacturer. The drug manufacturer must address any issues identified during the onsite inspection before the NMPA can proceed to the final stage of the review process.

Expert Review

Next, a panel of experts evaluates the data submitted in the new drug application package. The panel includes experts in pharmacology, toxicology, clinical medicine, statistics, and drug regulatory affairs.

The expert review evaluates the safety, efficacy, and quality of the drug, as well as the manufacturing process. The experts may request additional information or clarification from the drug manufacturer before making a final decision on the drug’s approval.

If the expert review identifies any issues, the drug manufacturer must address them before the drug can be approved for sale in China.

The NMPA considers multiple factors in its review process, including the drug’s safety, efficacy, quality, and manufacturing process. The length of the NMPA review process can vary, but it typically takes around 1-2 years for a new drug to be approved in China.

Post-Market Surveillance

Once a drug is approved for sale in China, the NMPA requires post-market surveillance to monitor the drug’s safety and efficacy. The drug manufacturer is required to submit periodic safety reports and conduct ongoing monitoring of adverse events. The NMPA may also conduct inspections of the drug manufacturing facility to ensure compliance with GMP guidelines.

China’s drug approval can be a challenging but necessary process for pharmaceutical companies seeking to develop and market drugs in China. The NMPA plays a crucial role in ensuring the safety and efficacy of drugs sold in China, and pharmaceutical companies must adhere to strict regulatory guidelines throughout the drug development and post-approval processes.

As China continues to develop its healthcare system, we can expect to see further developments in the drug approval process aimed at improving the efficiency of drug approval while maintaining high safety and efficacy standards.

Tran Doan – Director, Pacific Bridge Medical (PBM)
Ms. Doan leads Asian market research, regulatory, and consulting projects at PBM. She graduated with a B.A., Phi Beta Kappa, in Mathematics and Economics from Franklin and Marshall College.

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