The reform of new drug review and approval has changed, and the innovation and development of biological drugs have accelerated

In 2021, Cytiva and Longitude, the research arm of the Financial Times, released the Global Biopharmaceutical Resilience Index, which surveyed biopharmaceutical executives and healthcare industry decision-makers in 20 countries to measure the industry's ability to respond to global demand in five areas: government policy and regulation, talent pool, R&D ecosystem, production agility and supply chain resilience
.

In 2021, Cintiva and Longitude, research arm of the Financial Times, released the Global Biopharma Resilience Index

Based on the success of the index release, in 2022, Cintiva focused on one of the pillars of the index – government policy and regulation
.

In 2022, Cintiva will focus on one pillar of the index – government policy and regulation

In recent years, many countries and regions have accelerated the speed of drug development, especially since 2020, the review and approval of biological drugs has accelerated significantly, for vaccines and other emergency review varieties, the Drug Evaluation Center of the State Food and Drug Administration has also established a set of strict review linkage working mechanism, which has accelerated the process
of vaccine research and development in China.

In late 2020 and early 2021, Cytiva's Global Biopharmaceutical Resilience Index survey found that 70% of respondents rated the speed of their drug approval agencies as "good" or "very good"*

The system of accelerating the approval of new drugs originated in the United States, in the 1980s, just as the AIDS crisis broke out, because there were no drugs available for treatment in the United States, some AIDS patients participated in high-risk underground drug clinical trials, and groups launched large-scale demonstrations, believing that the FDA new drug review was too strict to lead to the situation that
no drugs were available.

Accelerate the review of the treatment of severely life-threatening drugs

Historically, many drug regulatory policies in the United States follow the bottom-up, due to the promotion of stakeholders, continuous revision and improvement of policies, and China's drug regulatory policies, with the development of the industry at different stages and different needs have also made corresponding reforms and adjustments
.

Let's review the reform and change of China's new drug review and approval policy:

Let's review the reform and change of China's new drug review and approval policy:

Since 2018, due to the promotion of pharmaceutical reform, China's innovative drug industry has gradually entered the harvest period, with nearly ten domestic new drugs approved for listing every year, more than 200 domestic INDs accepted, and the biopharmaceutical field has performed significantly
.

The drug review center optimizes the review process, strictly controls the review time limit, accelerates the review speed, strengthens the project supervision, and the review and approval continues to grow at a rapid rate

With the continuous optimization and improvement of policies and regulations, China's newly revised Measures for the Administration of Drug Registration in 2020 clarifies the accelerated listing and registration procedures for drugs including breakthrough therapeutic drug procedures, conditional approval procedures, priority review and approval procedures and special approval procedures, and drug registration applicants can combine the actual situation of the declared products and accelerate the process
of listing declaration through one or more mechanisms.

Breakthrough therapeutic drug procedures, conditional approval marketing procedures, priority review approval procedures and special approval procedures for drugs to accelerate the listing of drugs through one or more mechanisms to accelerate their marketing declaration

According to the 2021 Drug Review Report released by the State Food and Drug Administration:

According to the 2021 Drug Review Report released by the State Food and Drug Administration:

Breakthrough therapeutic drug procedures: In 2021, China received 263 applications for registration, and a total of 53 (41 varieties) were included in the breakthrough therapeutic drug program
.

Breakthrough therapeutic drug program:

Conditional approval: Of the 323 new drug applications (NDAs) proposed for approval by China in 2021, a total of 60 (38 varieties) were listed
after conditional approval.

Conditional approval:

Priority Approval: A total of 115 applications in China will be approved to apply the priority review and approval process in 2021
.

Priority Approval:

It can be seen that better regulations have greatly promoted better cooperation
between the government and enterprises.

Promoting drug review and approval is undoubtedly one of the important means to protect the public interest

At present, China's contribution rate to global pharmaceutical innovation has steadily increased, and it is gradually becoming an important force in
global pharmaceutical innovation.

Establish a scientific management mechanism for the whole process of supervision system, build a professional team, continuously optimize the review process, open regulatory communication, and do a good job in top-level design

In 2022, the Drug Evaluation Center of the State Food and Drug Administration publicly solicited opinions on the "Work Procedures for the Drug Review Center to Accelerate the Review of Innovative Drug Listing Applications (Trial)", according to the work procedures, the scope of varieties applicable to "accelerated review" is "innovative drugs included in the breakthrough therapeutic drug procedure", and the applicable stage is "the applicant has completed the exploratory clinical trial", and has the conditions to carry out key clinical trials until the approval of the listing, and the review is limited to 130 days, early intervention, research and review linkage, and rolling submission.

References:

References:

[1] The official website of the State Drug Administration, www.

[1] The official website of the State Drug Administration, www.

[2] 2020 Drug Review Report

[3] 2021 Drug Review Report

[3] 2021 Drug Review Report

*Data from the 2022 Biopharma Resilience Index Survey jointly sponsored by Financial Times and Cytiva

*Data from the 2022 Biopharma Resilience Index Survey jointly sponsored by Financial Times and Cytiva