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History and overview
The NMPA, formerly known as the China Food and Drug Administration (CFDA), traces its origins back to the earlier State Food and Drug Administration (SFDA). The SFDA underwent a transformation in March 2013, leading to its rebranding and restructuring as the China Food and Drug Administration, resulting in its elevation to a ministerial-level agency. In 2018, an additional name change was implemented to the “National Medical Products Administration” or NMPA as part of China’s government administration restructuring. This change also involved the incorporation of NMPA into the newly established State Administration for Market Regulation (SAMR). The NMPA’s administrative headquarters are situated in Beijing’s Xicheng District.
The responsibilities of the NMPA include overseeing the safety of drugs, medical devices, and cosmetics. It is responsible for issuing regulatory policies, drafting laws and regulations, and ensuring their implementation. The medical product registration process, quality control, post-market risk management, and emergency response procedures all fall under the NMPA’s purview.
NMPA drug registration
The Center for Drug Evaluation (CDE) plays a critical role in the approval process for clinical trials and pharmaceuticals. A key legal framework that governs various aspects of drug-related activities is the Drug Administrative Law (DAL), which encompasses drug development, registration, manufacturing, and the marketing of drugs. Additionally, the Drug Registration Requirements (DRR) outline specifications for classifications, clinical trials, and other pertinent details related to small molecule drugs, biologics, and more.
The classification of drugs is structured into different classes based on distinct criteria.
Class 1 – New drugs:
Class 1 includes innovative drugs that feature new chemical entities and have not been introduced to any market worldwide.
Class 2 – New Drugs:
Class 2 drugs are improved and new iterations of drugs derived from known chemical entities. These improvements can involve aspects like enhanced chemical structures, novel administration routes, and new indications.
Class 3 – Generic:
Class 3 includes domestic generic drugs that reference originator drugs accessible outside of China but are yet to be marketed within China. Additionally, these drugs must demonstrate consistency with the originator drugs in terms of quality and efficacy.
Class 4 – Generic:
Class 4 pertains to domestic generic drugs that reference originator drugs already on the market in China. Similar to Class 3, these drugs should exhibit conformity with the quality and efficacy of the originator drugs.
Class 5 – Imported Drugs:
Class 5 covers imported drugs that are seeking entry into the Chinese market. This category includes both drugs from the originator and non-originator sources.
Upon completion of both pre-clinical studies and clinical trials, the next crucial step in the drug development process involves the submission and subsequent review of the drug marketing authorization application. This phase signifies the transition from research and testing to seeking official approval for the drug’s commercial distribution and use.
As part of the evaluation process, drug samples from three separate batches are rigorously tested. This critical examination is carried out by the National Institute for Food and Drug Control Center (NIFDC).
The CDE takes a systematic approach to organizing technical reviewers who form panels responsible for the comprehensive evaluation of drug marketing authorization applications. This intricate process ensures that every aspect of the application is subjected to expert scrutiny. Upon the conclusion of the review process, if it is determined that all the application materials successfully meet the requirements set forth by regulatory authorities, an official acceptance will be granted.
Standard reviews for applications take 200 business days, while priority reviews are completed within 130 business days. In cases of urgently needed drugs or those for rare diseases, the review period is shortened to 70 business days. Should any deficiencies arise, applicants are required to respond to the CDE within 80 working days.
NMPA medical device registration
The Center for Medical Device Evaluation (CMDE) is responsible for reviewing medical device registration applications. In specific cases, certain medical devices are mandated to undergo a series of essential steps including safety registration, certification, and inspection. These processes are administered by the SAMR, ensuring the adherence of these devices to rigorous safety and quality standards.
According to the medical device regulations in China, medical devices are classified into three categories: Class I, Class II, and Class III devices. Class I devices are simple devices that pose the least risk, whereas Class II devices pose moderate risk that needs technical management and control, and Class III devices have the highest risk and require strict regulation.
The first step in the NMPA device registration process – preparing the required documents and specifications – typically takes approximately 2 months. Following this, local sample testing (type testing) should take roughly 6 months.
For some Class 2 and most Class 3 devices, a Clinical Evaluation Report (CER) or a local clinical study will be required, which is expected to take between 6 months to 1.5 years. Afterwards, the filing procedure with the NMPA involves a month of administrative work. Once submitted, it takes 3 to 9 months for the CMDE to complete the review process.
If there are any deficiencies which call for a supplementary submission, the process of assembling and submitting additional information could potentially take up to a year. Finally, as the last step in the registration journey, the NMPA conducts the conclusive review and issues the registration approval within 30 working days.
Contact us today for a free consultation with a China regulatory affairs consultant to discuss your specific needs.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.