New Accelerated Regulatory Paths in China

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At the end of August, China’s legislature finally approved the long-awaited Drug Administration Law. Capping the dizzying regulatory reform since 2015, the new law codifies many of the popular provisions, such as the 60-day IND default approval.

In this issue, we will look into the newly established accelerated channels for innovative drug approval. Under the new law, the NMPA will provide faster review and approval for drugs with significant unmet medical needs. For global developers, these channels will help accelerate the time to market, a major advantage.

The law dedicated a whole Chapter on the 4 types of accelerated approvals: Break-through, Conditional Approval, Accelerated Review, and Exceptional Approval.

The Break-through approval applies to therapies for diseases of life-threatening nature or severally impacting quality of life, AND, there is no treatment or significant unmet needs. If the drug can show clear clinical benefits, the sponsor can apply for Break-through designation. This is very similar to the US Break-through status.

Conditional Approval applies to 3 types of therapies: 1) the drug is for life-threatening conditions without effective treatment; 2) urgently needed therapies for public health reasons; 3) vaccines for sudden and serious infectious disease outbreak. The drug has to show certain efficacy data which can be used to predict overall benefits and risks. As the name suggests, the drug company needs to conduct additional commitment trials as a condition of such approval. The final regulatory approval will be hinged on the results of the commitment trial(s).

If the drug qualifies for either Break-through or Conditional Approval, the NMPA will provide Priority Review and Approval – faster timeline than regular approval. So far in 2019, the NMPA review time for NDA is about 9-10 months. The Priority Review promises even shorter time.

In addition, the law provides similar incentives to those drugs in major shortage, for major infectious diseases, for rare diseases (one of the 121 orphan diseases published by NMPA), for pediatric uses (including new formulation and dosage form), as well as vaccine for public health needs. The law treats China domestic and foreign companies equally, leveling a playing field.

The Exceptional Approval gives the NMPA the power to approve therapies to counter public health crises. An outbreak of SARS back in early 2000 would have qualify for this statute.

The new Drug Administration Law gives further incentive for innovative drug developers to bring therapies with significant unmet needs to patients quicker. In your clinical development planning, this factor should be taken into account. The new law makes China ever more important in global drug development.

The regulations and procedures of these designations are still being written. We shall see implementation guides in the following months. We will closely follow the development in this area.


About the Author:


Lei Liu is the VP of Regulatory Affairs of FMD. She has been working in the regulatory affairs arena for over 10 years. Over the past decade, she led teams to successfully execute over 150 registration cases for biopharma companies. She has includes MRCT application in China simultaneously with global trial, strategy consultation of China-Asian and China-US combined trial submission


About FMD K&L:

FMD is a full service clinical CRO focusing on innovative drug development. With its 1,700 employees in 20 offices in China, US, Japan, India, UK, The Philippines and Armenia, FMD has helped global drug developers advance clinical development for 12 years.

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