China: Registration of raw materials entering the composition or presentation of biopharmaceuticals

15 January 2020
Drug Substance
China: Registration of raw materials entering the composition or presentation of biopharmaceuticals
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China represents 20% of the world’s population, in 2018 was the fastest-growing patient group for health products and had the second-largest body of patients for the pharmaceutical industry. It is an increasingly important market for the global pharmaceutical industry.

During this growth, China has made great strides towards better coordination with other markets—it became a member of the International Committee for Harmonisation (ICH) in 2017 and joined its management committee in 2018.

However, despite this progress there remain some challenges, especially around the registration of raw materials.

“In 2017, China initiated significant healthcare and regulatory reforms aimed at encouraging innovation in new medical drugs,” said Christina Juli, Global Tech Regulatory Affairs manager at Boehringer Ingelheim. “As part of the reforms, the Chinese Health Authority, the National Medical Products Administration (NMPA), announced the Drug Master File approach for active pharmaceutical ingredients (APIs), excipients and primary packaging material.

“From the end of 2017, it became mandatory that the suppliers of APIs, excipients and packaging materials are responsible for registering their material before the drug registration application.”

To address these challenges, BioPhorum has written an Industry Reflection of the Registration of Raw Materials Entering the Composition or Presentation of Biopharmaceuticals in China.

The Chinese requirements for excipients and packaging materials used in biopharmaceuticals are far beyond those of other countries—not because they are different, but because they are used for parenteral forms. This view is very different from other agencies. And while many agencies ask for details of a component’s quality and its impact on products, the Chinese requirements ask for historical information, e.g. manufacturing process development and its control strategy. This information is typically proprietary and many suppliers are reluctant to share it with license holders.

“The BioPhorum paper aims to facilitate collaboration between the global pharmaceutical industry, the suppliers of APIs, excipients and primary packaging material, as well as the NMPA,” added Juli. “Also, Chinese compliance challenges are addressed to identify opportunities to accelerate regulatory approval and integration with global regulatory standards.”

The different requirements and their impact on suppliers are covered in the paper. It lists all of the details needed for a Chinese registration in a single place and will help suppliers be prepared if they want to introduce their products into this vast market.

The paper also summarizes the ICH principles of the registration process for raw materials and compares these to the Chinese approach for a registration. The impact of the Chinese requirements and the availability of drug products to its population are also discussed. The paper:

  • Allows a quicker registration process in China and makes product approvals and their commercialization faster
  • Simplifies the supply chain when an excipient or a packaging component is changed
  • Creates an opportunity to strengthen relationships between suppliers and the NMPA.

Some aspects of the paper were discussed at a CASSS WCBP conference workshop on the Regulatory Challenges in China at the end of January 2020, where Juli co-chaired the session. BioPhorum is also looking at opportunities to present the paper at a global supplier conference in the next few months and to discuss it with the NMPA and the ICH.

For more information, contact

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