Ddu has gradually made its way through Europe by attending the CPhI Worldwide 2017 in Frankfurt and Medica 2017 in Düsseldorf, Germany(RELATED: Ddu Attended CPhI Worldwide in Germany). During conversations with manufacturers, ICH was frequently mentioned. Since China was admitted as one of the regulatory members of ICH in June of last year, it was now placed at the forefront of the discussions.

Due to the amount of interest generated, Ddu herewith discusses with what ICH is, the changes it will bring to the requirements of clinical trials and its influence on the medical trade.

1. What is ICH?

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was co-founded by regulatory members: the European Commission (EC), the US Food and Drug Administration (FDA), the Ministry of Health, Labour and Welfare of Japan (MHLW) also represented by the Pharmaceuticals and Medical Devices Agency (PMDA).

Due to the special nature of medicinal products, every country sets its own regulations for the purpose of safety and profits of the products. Thus, ICH is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registrations. Since its inception in 1990, the ICH has gradually evolved to respond to the global drug development with the mission to achieve greater harmonisation worldwide. This will help to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.

China’s admittance into the ICH is bound to remove barriers to international market entry for Chinese medicines and facilitate delivery of medicines from Europe and America to Chinese people.

2. What changes are brought to clinical requirements after joining ICH?

In order to understand this, we firstly have to look at the differences between China’s current Good Clinical Practices (GCP) and that of the ICH.

To sum up, China’s GCP focuses on controlling management of and approvals of clinical research while the GCP of the ICH attaches importance to the supervision on the processes of clinical trials.

3. Is it good or bad for the medical trade?

Joining the ICH means to raise the standards and regulations for medicines, thereby bringing the research of domestic drugs and regulators under more rigid scrutiny.

But is it good or bad for the medical trade?

• From perspective of local biosimilar companies

After joining the ICH, local biosimilar companies will face reforming pressure from more and more international biosimilar companies as well as competitors with original bio-pharmaceutical products who will surge into Chinese market.

If they fail to meet the requirements of the ICH, they are to be replaced without a doubt. Statistics shows that after the introduction of consistency evaluation for biosimilars, 3000 out of 5000 biosimilar companies will be confronted with policy tests and after fully employment of the ICH, two-thirds of them will be washed out.

• From the perspective of local innovative pharmaceutical companies

Local innovative pharmaceutical companies could greatly benefit from joining the ICH since it would speed up the process of listing  their products on the market.

However, joining the ICH also places the Chinese medical industry into global competition where Chinese medical companies will compete directly with medical giants. There is still a long way to go because of greater difficulties in drug research, clinical trials and increase of costs.

• From the perspective of multinational companies

Multinational companies would benefit since it would be easier and more cost-effective for them to list their products on the Chinese market.

Under the policies of priority reviews and international multicentre clinical trials, introduction and registration of new drugs will be greatly accelerated, making it possible to list the products in China’s market at the same time or earlier.

• From the perspective of third-party service providers

The whole CRO and even SMP and CMO industries could benefit, but they have to make sure they are up to the standards of the ICH.

4. Conclusion

Joining the ICH may cast some influence on local Chinese medical companies for a short period of time but in the long run, it will boost the development of the whole industry.

As the leading global pharmaceutical & medical device B2B online platform, Ddu is will be perfecting its third-party services for translation, registrations and clinical trials, to provide a one-stop solutions to all users on the platform.