With the deepening of the reform of its pharmaceutical industry in the past few years, since joining the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), China has added or amended more and more laws and regulations to meet the needs of the world’s drug developers. During DIA China 2019 in Beijing in late May, topics related to the reform of the Chinese regulatory system reform dominated discussion. Here are some highlights:
eCTD: opportunity and challenges
How to implement eCTD smoothly in China is both an opportunity and a challenge for the pharmaceutical industry and drug regulatory authorities, as panelists at DIA China said.
In October 2017, China’s Center for Drug Evaluation (CDE) solicited public comment on “Electronic Drug Common Technical Documents (eCTD) Modules and Guidelines for Application Documents in eCTD format of Chemical Generics” (See Cortellis Regulatory Intelligence, IDRAC 261096). This document drafted the structure of the eCTD which is aligned with international rules, and outlined guidelines for eCTD implementation of chemical drugs.
China is moving forward on eCTD reform. Earlier this year, China made an important milestone for eCTD implementation when the CDE published “Soliciting Public Comment on Technical Standards (Draft) and Review Standards (Draft) of Electronic Common Technical Document (eCTD)” (See Cortellis Regulatory Intelligence, IDRAC 291150).
Chinese authorities face several challenges in the practical implementation of eCTD:
- The eCTD infrastructure requires a comprehensive security system to ensure the safety and authenticity of the declaration materials submitted by the applicants through eCTD so they cannot be modified or stolen by others. The online submission of large-capacity electronic documents is more difficult for China’s current network infrastructure. In addition, the electronic declaration documents are large and the storage requirements of the system are high.
- Drug registration and declaration materials submitted in the form of eCTD require expertise and are difficult to produce. The number of professionals familiar with this work in China is small. How to make declaration materials that can pass the verification of eCTD information system requires extensive training and practice. For reviewers of drug regulatory agencies, skilled use of the eCTD information system to review drug registration declaration data will likewise require a lot of training and practice.
“This revision, following recommendations from industry, encourages innovative drug development while strengthening data protection.”
Another wish of the authorities, as noted at DIA China, is to extend eCTD to the registration and declaration of traditional Chinese medicine preparations in the future. At present, eCTD has been tried out in China for chemical generic drugs. As a characteristic of China, traditional Chinese medicine preparations occupy a large proportion in the domestic pharmaceutical market. In order to better promote Chinese medicine preparations abroad and adapt to the worldwide popular eCTD declaration mode, pharmaceutical enterprises should strictly comply with the requirements of CTD on the content of declaration data to improve the quality of declaration materials.
Amendment of the Pharmaceutical Administration Law of China
Another key issue discussed at DIA China was the amendment of the Pharmaceutical Administration Law of China and how it will influence regulatory pathways. Ruilin Song, executive president of the China Pharmaceutical Innovation and Research Development Association, moderated a session on the law and demonstrated with the panel how its revision could take China to the next level on the world pharma stage.
The law was first issued in 1984 and revised for the first time in 2001. With the rapid development of drug research and development and the gradual deepening of drug regulatory reform in China, now, 18 years later, the systematic and structural revision of the Pharmaceutical Administration Law is an important measure to promote the achievements of major reforms in the field of drug regulation to become law.
This revision, following recommendations from industry, encourages innovative drug development while strengthening data protection. It also seeks to improve the efficiency of the examination and approval system and reinforce risk management and post-marketing supervision. Its aims to include a balance between innovative drugs and generic drugs, a streamlining of administration and ensuring life cycle supervision.
The law once finalized should bring major improvements for pharma stakeholders. As an example, the provision for the Establishment of Central and Local Ethics Committees could potentially greatly shorten the time it takes to submit an IND or NDA. If a multi-center clinical trial is conducted within the territory of China, a central ethics committee may be set up to conduct a unified ethical review.
“Another wish of the authorities, as noted at DIA China, is to extend eCTD to the registration and declaration of traditional Chinese medicine preparations in the future”
Another example would be clearly defining the time limit for drug approval, which can help enterprises effectively evaluate the registration progress and improve the efficiency of drug registration.
In total, there are nine relevant chapters under revision and 20 articles amended or added. The final version of the Pharmaceutical Administration Law is expected to be published later in 2019.
Editor’s note: This is the first of a two-part series in Life Sciences Connect on changes to the regulatory system in China. Part two will examine discussion on clinical trials from both DIA China 2019 in Beijing and DIA 2019 in San Diego.
The Chinese regulatory documents highlighted in this article, noted by their Cortellis Regulatory Intelligence track number (IDRAC), are all collected, curated and translated in Cortellis Regulatory Intelligence, the timely and comprehensive solution that spans all regulatory functions across the biopharma R&D lifecycle.