Advancements in Consistency Evaluation: A Comprehensive Analysis

Consistency evaluation plays a crucial role in ensuring the quality and efficacy of generic drugs. Since the implementation of the "Evaluation of Consistency in Quality and Efficacy of Generic Drugs" policy and regulations in 2016, consistency evaluation of chemical generic drugs has made significant progress. This article provides a comprehensive analysis of the advancements in consistency evaluation, highlighting key statistics and trends through nine informative charts.

1: Variation in the Number of Accepted Consistency Evaluation Applications
Since the introduction of policies related to consistency evaluation of generic drugs, there has been a gradual increase in the number of accepted applications. As of December 31, 2023, the China Drug Evaluation Center (CDE) received a total of 5,429 supplementary applications for consistency evaluation, covering 872 different drug varieties. Out of these, 1,172 varieties have successfully passed or received equivalent evaluation, with a total of 8,543 accepted applications.

2: Changes in the Registration Classification of Consistency Evaluation Applications
The chart illustrates the changes in the registration classification of consistency evaluation applications for generic drugs. It demonstrates that pharmaceutical companies have adjusted their pace of drug registration submissions since the introduction of consistency evaluation policies in 2016. This has led to improved drug quality and efficacy. Notably, the number of chemical generic drugs that underwent consistency evaluation in different categories (such as domestic unmarketed drugs, domestic marketed drugs, and imported drugs) has significantly increased.

3: Evolution of Consistency Evaluation by Companies and Drug Varieties
The chart presents the progression of consistency evaluation by highlighting the changes in the number of evaluated drug varieties and the companies involved from 2017 to 2023. The increasing number of evaluated drug varieties and participating companies signifies the improved research and development capabilities of pharmaceutical companies, as well as their commitment to complying with national policies.

4: Top Companies in Consistency Evaluation
This chart showcases the top companies that have excelled in consistency evaluation. Based on the number of accepted applications, Sichuan Kelun Pharmaceutical, Qilu Pharmaceutical, and Chengdu Baiyunshan Pharmaceutical are the leading companies. Yangtze River Pharmaceutical and Fuan Pharmaceutical are also among the top performers. The chart further highlights the number of evaluated drug varieties for each company.

5: Consistency Evaluation Statistics from 2017 to 2023
Analyzing the data from 2017 to 2023, this chart provides an overview of consistency evaluation statistics, including the number of accepted applications and evaluated drug varieties. It reveals that Qilu Pharmaceutical has the highest number of accepted applications, followed by Sichuan Kelun Pharmaceutical and Yangtze River Pharmaceutical. These companies have consistently demonstrated their commitment to consistency evaluation.

6: Changes in the Number of Evaluated Drug Varieties
The chart showcases the changes in the number of evaluated drug varieties by Sichuan Kelun Pharmaceutical, Qilu Pharmaceutical, and Yangtze River Pharmaceutical from 2017 onwards. The data indicates fluctuations in the number of evaluated varieties over the years, reflecting the dynamic nature of consistency evaluation efforts.

7: Consistency Evaluation by Therapeutic Area
This chart highlights the distribution of consistency evaluation results across different therapeutic areas. The data reveals that a wide range of therapeutic areas are covered by consistency evaluation, with the highest number of evaluated applications belonging to the anti-infective drug category (24%). Neurological and cardiovascular drugs also account for a significant proportion, at 15% and 13% respectively.

The consistent evaluation of generic drugs has witnessed significant progress since the implementation of relevant policies and regulations. Pharmaceutical companies have actively participated in the process, resulting in improved drug quality and efficacy. The provided charts offer valuable insights into the advancements in consistency evaluation, highlighting the contributions of leading companies and the distribution of evaluated drug varieties across therapeutic areas. These developments reflect the industry's commitment to ensuring the availability of high-quality generic drugs for the benefit of patients and healthcare systems.