At 4:00pm on June 19, 2017, China Food and Drug Administration (CFDA) has officially announced that CFDA will become a member of ICH, the International Council for Harmonization. At the same time, ICH released the news on its official website. It will start a new era of the globalization of Chinese pharmaceutical industry,which means Chinese public can have quicker access to new international drugs.
From 31 May to 1 June 2017, ICH held its first meeting in 2017 at Montreal, Canada, and the representatives of CFDA attended the meeting upon invitation. In the meeting, ICH Assembly approved the CFDA as a new Regulatory Member. Yuan Lin emphasized that ICH enrolls new members not based on country, therefore “it is CFDA that joins ICH instead of China”.
After ICH meeting, as approved by the State Council, Minister Bi Jingquan of CFDA wrote to Dr. Theresa Mulin, chair of ICH Management Committee on June 14, two weeks after the announcement of voting result, to officially confirm that CFDA joins the ICH as the 8th regulatory member in the world.
ICH was initiated by the drug regulatory agencies and industry associations of the US, European Community and Japan in 1990 and has become a technological international non-governmental organization registered under civil law of Switzerland from a closed international conference mechanism in December 2015. ICH’s mission is to coordinate and establish a safe, effective, and high-quality international technological standard and regulations in drug registration technology field and serve as a foundation for regulatory agencies to approve the marketing of drugs, to reduce the development and marketing cost of drugs and drive the commercialization of a safe and effective innovative drugs. With over 20 years of development, the technical guides issued by the ICH have been accepted and translated by the main national drug regulators in the world as the formulation mechanism of core international rules in the field of drug registration.
“Joining the ICH means the Chinese pharmaceutical industry will take part in global competitions.” As warned by Yuan, the pharmaceutical industry in China as a whole, is behind the developed countries, such as Europe, the US and Japan, especially in terms of innovation and R&D capabilities. Domestic enterprises should grasp the opportunity, study and understand the ICH guidelines, and apply these technical requirements to product developments, registrations and productions to improve product safety and quality, as well as core competitiveness.
Anyhow, CFDA believes that after joined ICH, the gap with international standards in technical requirements will be narrowed or even eliminated. It will become easier for enterprises to include China in global development path of innovative drugs, and enterprises will become more active to work on innovative drug developments and registrations in China. It can be expected that more and more innovative drugs will be commercially available in the Chinese market in the near future to meet the drug demands.