Gaining the Initiative! SDA Becoming an ICH “Administrator”

According to the official news of SDA (State Drug Administration of China, formerly, CFDA) on June 7, in the 2018 first meeting of ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) held in Kobe, Japan, SDA was absorbed as a member of ICH Management Committee. What needs to be emphasized is that unlike CFDA’s joining ICH as an ordinary member last year, this time SDA become a member of ICH Management Committee, namely, an "administrator" that has a greater say and can even participate in policy making!

Figure sourced from SDA official website

We know that CFDA was absorbed as a full member of ICH in 2017 first meeting of ICH held in Montreal, Canada during May 31-June 1 last year, which attracted great attention from the medical world. Only one year later, China has been successfully absorbed as a member of ICH Management Committee, showing how "amazing" the work efficiency of SDA is.

It is reported that ICH was jointly initiated and found by the drug regulators of the U.S., EU and Japan in 1990, and had long been under the state of closed international meeting mechanism; other countries were not qualified for participation, but could only sit in as observers, not to mention a say for rule making. However, the organization started a reform in 2012, and transformed to a technical international non-governmental organization registered under Swiss Civil Code at the end of 2015.

ICH has now 14 members, including the founding members EU, U.S. and Japan, Canada, Switzerland, Brazil, South Korea and China (those five and the founding members are regulatory members), and also 6 industry members including EFPIA, JPMA, PhRMA, BIO, IGBA, and WSMI, and has 23 observers. It is reported that the pharmaceutical output value of ICH members accounts for 80% of the global pharmaceutical output value, and the pharmaceutical R&D expenditures invested by ICH members account for 90% of global pharmaceutical R&D expenditures, therefore, ICH has the absolute say in the global medical world.

According to the original provision of ICH, only by implementing 4 and more of its 5 secondary guidelines (i.e., M4, E2A, E2D, M1 and E2B) can a member become member of ICH Management Committee. After multiple times of adjustment, this provision is now: by implementing at least one of the secondary guidelines, and fully implementing the secondary guidelines by July 1, 2022. According to the announcement of SDA on the application of ICH secondary guidelines issued this year, SDA requires the application of M4 from this February, E2A, M1 and E2B(R3) from this May, E2D from this July, and all secondary guidelines by July 1, 2020, to meet the conditions for joining ICH Management Committee. Therefore, this success in becoming a member of ICH Management Committee is a natural thing that comes from efforts of SDA.

According to ICH, the purposes for the founding are: 1. Harmonize the technical requirements for registration of pharmaceuticals for human use among member states through international harmonization; 2. Innovate the new drug R&D technical standards and improve the research quality; 3. Save human, animal and material resources, reduce development cost and shorten development cycle; 4. The most important and core purpose is to increase the new drug R&D, registration and marketing efficiency.

Then, what influences will be brought to China’s pharmaceuticals by becoming an ICH "administrator"? This might be what we, medical practitioners, is most concerned about. In my opinion, the influences mainly include:

1.    Promote the drug review and approval of China to be normalized and efficient: one purpose for the founding of ICH is to increase the registration and marketing efficiency; ICH’s much experience in drug review and approval over the years can help promote SDA’s drug review and approval to be normalized and efficient.

2.    Help push Chinese drugs to foreign countries: pushing Chinese drugs to foreign countries has been a "mountain" to Chinese pharmaceutical enterprises! This joining as ICH and becoming an ICH "administrator" mean that China will have a greater say; China will gain the initiative and can even directly participate in policy making, which will have great influences on Chinese drugs’ going abroad.

3.    Help the marketing of overseas new drugs in China: Joining ICH means that China’s gap in terms of drug review and approval with other ICH member countries will be narrowed, which will reduce many approval items (repeated items will not be subject to approval) for the marketing of new drugs of other countries in China, to achieve improvements in fund and approval speed.

The pharmaceutical R&D and regulation capacity of China has been stably improving in recent years, and this success in becoming a member of ICH Management Committee reflects that China’s drug regulatory capacity is recognized by the world. As China’s pharmaceutical industry continues to develop rapidly, I believe that China will gain more and more say in the international pharmaceutical system, to effectively guarantee the sound development of China’s pharmaceutical market.