NEWS

nterpretation of the 2024 Drug Review Report

The "2024 Drug Evaluation Report" shows that China's drug evaluation and approval system has made remarkable progress under the principles of innovation-driven development, international alignment, and prioritizing people's livelihood. The following is an interpretation from four aspects: key data, policy effectiveness, industry trends and future directions:

I. Key Data Highlights

Innovative drugs are being approved at an accelerated pace

Class 1 innovative drugs: 48 varieties were approved throughout the year, covering nearly 20 therapeutic areas such as oncology (accounting for 42.54%), neurological diseases, and anti-infection. Among them, 17 passed priority review and 11 were conditionally approved for marketing.

Breakthrough therapy drugs: 91 indications were included (up 30% year-on-year), with anti-tumor drugs accounting for the highest proportion, such as tormoletinib capsules, etc.

2. Medication guarantee for special groups

Rare disease drugs: 55 varieties were approved, 20 of which passed the priority review, and 2 were conditionally approved (such as Epazepam hydrochloride capsules).

Pediatric medications: 106 varieties were approved (71 new marketing applications), and 35 expanded indications for children were provided, filling the gap in pediatric medications.

3. Improvement in review efficiency

The number of concluded cases reached a new high: 18,259 cases were concluded throughout the year (+16.2%), and the proportion of technical review categories exceeded 80%.

Priority review acceleration: The review period was shortened from 200 days to 130 days, and 110 priority reviews were completed throughout the year (involving 74 varieties).

4. Internationalization and alignment with standards

Introduction of overseas drugs: 89 overseas drugs that have been approved for marketing (64 of which are being marketed in China for the first time).

ICH has been fully implemented: 71 guiding principles have been put into practice, and the review standards are increasingly similar to those of Europe and the United States, facilitating global synchronized research and development.

Ii. Analysis of Policy Effectiveness

The acceleration channel mechanism takes effect

Shorten the research and development cycle through procedures such as breakthrough therapy, conditional approval, and priority review. For instance, the review period for shortage drugs has been shortened to 70 days, and a total of 226 shortage drugs have been approved in the past five years.

2. R&d resources are concentrated in high-demand areas

Leading research and development of anti-tumor drugs: In the application for clinical trials of chemical drugs, anti-tumor drugs account for 41%, and biological products account for 55%. Among the innovative drugs on the market, anti-tumor drugs account for 36%.

The modernization of traditional Chinese medicine is accelerating: Applications for clinical trials of traditional Chinese medicine have increased by 33.33% year-on-year, promoting innovation in traditional medicine.

3. The technical guidance system is well-developed

A total of 73 technical guidelines were released throughout the year, bringing the total to 555, covering cutting-edge fields such as cell therapy and gene therapy.

Iii. Industry Trends and Challenges

1. Optimize the R&D structure

The rise of targeted and gene therapy: Anti-tumor drugs account for more than half of biological products, indicating that precision medical technology has become a hot topic.

Clinical value orientation: Enterprises focus on policy support areas such as rare diseases and children's medication, and seize the market through differentiated competition.

2. International competition intensifies

After the implementation of ICH standards, domestic enterprises need to enhance the quality of their research and development to participate in global competition, while international pharmaceutical companies are accelerating their layout in China.

3. Deepening of regulatory science

Introduce new concepts such as "decentralized clinical trials" to promote the flexibility of rare disease drug research and development.

Iv. Future Outlook

1. Policies have been continuously optimized

Deepen mechanisms such as priority review and conditional approval to promote the listing of drugs urgently needed in clinical practice.

Strengthen international multi-center clinical trial cooperation to promote global synchronous research and development and approval.

2. Enterprise strategic direction

Focus on high-demand areas such as anti-tumor, neurological diseases, and rare diseases, and accelerate research and development by leveraging policy dividends.

Strengthen early communication: Through the communication and exchange mechanism of the Center for Drug Evaluation (4,912 meeting applications were handled throughout the year), reduce technical risks.

Sum up

The year 2024 is a crucial one for the coordinated development of China's pharmaceutical innovation and regulatory science. The review data and policy practices of 2024 indicate that China's pharmaceutical regulatory system is rapidly evolving towards the direction of "efficiency, openness and internationalization". The three main lines of improving review efficiency, strengthening the guarantee of special drugs, and aligning with international standards will drive the industry to transform from "mainly imitating" to "innovation-driven". In the future, with the deepening implementation of ICH standards and the innovation of regulatory science, China is expected to play a more core role in the global pharmaceutical industry chain and provide patients with more high-quality "Chinese solutions".