ICH flooded the screen, China’s joining of ICH not officially recognized yet

It has been reported early in the morning of June 2 that CFDA was voted to formally become a full member of ICH at the venue in Montreal, Canada.

What is ICH?

ICH (full name: International Conference on Harmonization of Requirements for RegistrationPharmaceuticals for Human Use) is an international harmonization organization founded by the Europe, Japan and the U.S. in 1990 for harmonization of existing differences of tripartite countries in technical requirements for registration of pharmaceuticals for human use.

What is the purpose for the founding of ICH?

In summary, there are mainly 4 purposes for the founding of ICH:

Firstly, harmonize the technical requirements for registration of pharmaceuticals for human use among member states through international harmonization;

Secondly, innovate the new drug R&D technical standards and improve the research quality;

Thirdly, save human, animal and material resources, reduce development cost and shorten development cycle;

Fourthly, the most important and core purpose is to increase the new drug R&D, registration and marketing efficiency.

3. Has China really joined ICH?

News from unofficial sources said that China’s application for joining ICH had been passed by voting at the venue in Montreal, Canada early this morning, however, before it is confirmed officially, I’d like to discuss the reliability of this news by "speaking on hearsay evidence".

I did not find any official news that China has become a member state of ICH after searching on ICH website and CFDA website, and the only related official news is as shown in Fig. 1, according to which, CFDA Minister Bi Jingquan met Dr. Theresa Mullin, Chair of the Management Committee of ICH, on May 19, and communicated regarding China’s joining of ICH, etc.

Fig. 1 CFDA news on May 22

China Food and Drug Administration

Bi Jingquan met Dr. Theresa Mullin, Director of Office of Strategic Programs, CDER, FDA and Chair of the Management Committee of ICH

Issued on May 22, 2017

CFDA Minister Bi Jingquan met the delegation led by Dr. Theresa Mullin, Director of Office of Strategic Programs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA) and Chair of the Management Committee of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) in the afternoon of May 19, 2017. Both parties exchanged opinions on promotion of drug innovation through regulatory reform and China’s joining of ICH, etc. Bi Jingquan delivered to Dr. Mullin a letter of congratulation to convey to the newly appointed FDA Commissioner Scott Gottlieb; and Dr. Mullin handed over a greeting letter from Gottlieb to Bi Jingquan. CFDA Vice Minister Wu Zhen and relevant directors of CFDA's related departments attended the meeting.

This exchange seems to have good effects according to the subsequent reports, because China filed the application for joining ICH subsequently, however, it seems inappropriate to say that China has joined ICH. I did not find China in the query of ICH member states, and it’s worth mentioning that Taiwan, China (Chinese Taipei) has joined ICH as an observer.

Fig. 2 ICH members published on ICH website

It is certain that the Europe and America cannot afford to ignore the Chinese new drugs as the Chinese pharmaceutical community has advanced by leaps and bounds in recent years, and it is a matter of time before ICH accepts China as long as China files the application. Then, will China join ICH this year and will the application of China be passed very soon? I did not find any issue for discussing the joining of China by querying the recent meetings of ICH (Fig. 3), therefore, it may not take too long to approve China’s joining of ICH, however, some time is needed. News from unofficial sources said that the meeting early this morning had approved the joining of China. I don’t know whether it was an interim and additional issue. I hope so, but it is still to be verified.

Fig. 3 Issues of recent ICH working meeting held in Canada

4. What are the influences that would be brought to the Chinese pharmaceutical community if China joined ICH?

Firstly, joining ICH is certainly a good thing, which will practically solve the issue that it has been difficult for Chinese drugs to enter the international market. Secondly, joining ICH enables China to get on the "high-speed railway" of the new drug R&D of the Europe and America.

The achievements obtained by ICH in reducing the repetitive work in the process of new drug product development and technical material application since its founding are obvious, mainly manifesting as: a. Promoting the exchanges between member states and between enterprises and authorities, and harmonizing requirements for pharmaceutical product registration among member states through communication; b. The use of the guidelines effectively reducing the repetitive research of member states, saving cost and shortening development time.

Seen from the positive effects obtained by ICH, it is necessary for China to join ICH. Certainly, some experts have noted that there are many differences and divergences in the executive standards of CFDA and ICH, and it may lead to reform of CFDA standards subsequently no matter China joins ICH as a full member or observer. Therefore, it is necessary for Chinese pharmaceutical enterprises to start to carefully study the guidelines of ICH.

Author: Muzi