Writer: Minhua Chu,Donglei Mao
Editor: Justin Fischer
On June 3, China’s National Medical Products Administration (NMPA) was re-elected as a member of the ICH Management Committee at the first 2021 General Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The NMPA announced the news on its website two hours after the Assembly closed.
The NMPA announced the news on its website two hours after the Assembly closed, source: NMPA website
Initiated by the EU, the US, and Japan in the 1990s, the ICH is an international Standards Development Organisation (SDO), that is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Now it has 18 members and 33 observers.
Tetsuomi Takano, Senior Strategic Director of Clinical Development Service for Labcorp Japan and an expert in drug administration and clinical development in China and Japan told PharmaDJ that all new ICH Management Committee members are elected every three years, reviewing their performance and implementation of ICH guidelines.
It is exciting news, said Takano. The NMPA stands in the international arena with clear goals and intentions and will actively participate in the ICH’s international affairs in the future.
Dr. Song Ruilin, Executive President of the China Pharmaceutical Innovation and Research Development Association (PhIRDA), said that NMPA's re-election as an ICH Management Committee member shows the the recognition of China's drug innovations, scientific adminstration, and technical review capabilities. It is a great show of the NMPA’s contribution to the ICH in the past three years.
Dr. Zhang Dan, co-founder of ClinChoice, a clincial CRO in the US and China,
said that this is another milestone after the NMPA (formerly known as the CFDA) joined the ICH as a regulatory member on March 30, 2017 and was elected to be an ICH Management Committee member in June 2018. Zhang is also the head of the International ICH E19 IFPMA Expert Committee and an expert in the NMPA ICH Working Group.
Why was the NMPA re-elected?
According to Takano, to the regulatory agencies who gain membership through expedited process (i.e. NMPA), an important indicator for re-election for the need to implement up to 75 percent of ICH guidelines, including all ICH Tier 1 and Tier 2 guidelines.
At the recent DIA (Drug Information Association) China 2021 Annual Meeting, Zhou Siyuan, Deputy Director of the Center for Drug Evaluation (CDE) of the NMPA and Director of the ICH China Office, also gave a report on the NMPA’s work on ICH.
The NMPA established the ICH working office in July 2017 and has released a large number of ICH guidelines. Zhou said that the NMPA had already implemented three ICH Tier I guidelines before becoming a member of the ICH.
ICH working office column in CDE website, source: CDE website
In 2018, the implementation schedule and roadmap of five ICH Tier 2 guidelines were clarified. Based on the plan, the NMPA should fully implement three and all five ICH Tier 2 guidelines in 2021and by 2023 respectively, and 50% of ICH Tier 3 guidelines by 2021.
NMPA fulfilled its ICH membership obligations well and comprehensively, said Zhou.
Currently, there are 55 ICH Tier 3 guidelines. As of May 2021, 40 ICH Tier 3 guidelines have been fully implemented, three are in the working and are expected to be implemented by the end of this year, one will be implemented in 2022; and two are expected to be implemented in the Chinese Pharmacopoeia 2030 edition.
In addition to the implemention the guidelines, NMPA also meets the qualification requirements in participating meetings and sending experts for harmonization works.
Zhou said that the NMPA has sent representatives to participate in the ICH's annual meetings and pre-conference conducting teleconferences since 2018. It takes part in reviewing the Rules of Procedures, work plan harmonization, new topics selection, ICH guideline implementation and training. It also participates in the discussions about Expert Working Groups (EWGs). Since joining the ICH in 2017, 71 meetings have convened.
Additionally, the NMPA has sent experts to all ICH EWGs since joining ICH. Up to now, 69 experts have participated in 36 EWGs. 1,026 topic harmonization teleconferences have been conducted between August 2018 to May 2021, an average of 30 per month.
What is most impressive is that the NMPA listens to the industry on each technical guideline and sets a timeline for implementation, so that the companies have adequate plans, Takano said.
The NMPA has been actively particpating in ICH works and has performed well, therefore gaining re-election. Zhang explained.
What has changed?
Chang Jianqing, Vice President of Regulatory Affairs at Tigermed, a Chinese clinical CRO, said, ICH’s guidelines are basic criteria in the development and manufacture of innovative medicines worldwide. Based on them, the regulatory authorties in different regions develop their technical guidelines to meet their conditions, such as the guidelines for clinical studies in specific therapeutic areas.
Chang also said that Chinese drug developers wish to go to the global market and meet international standards. Other experts also told PharmaDJ that they believe China's regulatory system needs to embrace international standards, rather than sticking to its own criteria.
Zhou expressed similar opinions in his presentation, explaining that joining the ICH promotes drug innovation and drives reforms of the regulatory system.
On March 4, 2016, the NMPA released new classifications for chemical drugs, defining Class I (innovative drugs) as the new molecular entity (NME) globally and clarifing the reference drugs of generics shall be orginal drugs.
Without the adoption of internationally accepted technical requirements, we cannot do that. The implementation of ICH guidelines has comprehensively enhanced the technical requirements for drug development and registration in China. Zhou said.
In July 2020, the revised “Drug Registration Management Measures” were implemented. Some measues to accelerate review were instated. The ICH “E” Series (Efficacy Guidelines) provides the norms to control drug safety risks and make the implicit consent for clincial trials possible.
The implementation of the ICH guidelines has promoted the alignment of technical requirements with international standards, multinational companies can bringing early stage projects into China, and simultaneous development and registration are gradually becoming possible, one CDE offical said at the ICH guidelines briefing meeting. “Joining ICH has accelerated the speed of drug launches in China to meet public demand for medicines.”
With the implementation of ICH M4, E5 and E17 guidelines, the reigstration documents filed to the FDA and EMA can directly be used in the application to the NMPA. In 2020, there are 6 drugs realize the simultaneous registration in China and other countries.
Joining the ICH also deepened the communication and cooperation between the NMPA and other ICH members of regulatory agencies and the industry. Takano said that the Asia-Pacific region will become the center of the global pharmaceutical market in the future, and the cooperation between the regulatory authorities of Japan and China will help improve the status of both countries. The NMPA and Japan’s PMDA (Pharmaceuticals and Medical Devices Agency) held a joint regional public meeting on June 18.
Next step, the NMPA will continue to strengthen communciations and cooperation with other regulatory agencies and international industry associations. It will invite ICH experts to training in ICH guidelines, conduct seminars around the implementation of difficult guidelines (i.e. M4, E17), and improve the construction of the domestic guidelines system.
In the future, the implementation of ICH guidelines will continue. The NMPA will promote the comprehensive implementation of ICH guidelines in China (see the table below).
At the same time, the NMPA will establish the ICH training mechanisms for its personnel. According to Zhou, the NMPA plans to release 50–60 guidelines per year in next 3–5 years. He hopes the domestic technical guidelines can be significantly improved with the implementation of ICH guidelines.
“The NMPA will deepen the work on ICH and make efforts to protect and promote public health in China and around the world, Zhou Siyuan said.