CPhI China launched the PharmaExcipients China in 2013, which has grown rapidly into a one-stop high-end trade exchange platform. The exhibition will be hosted at the Shanghai New International Expo Centre (SNIEC) from June 22-24, 2020 and gather over 100 Chinese and overseas industry giants including DuPont (E3D26), BASF (E3E40), Merck (E3E31), Meggle (E3E02), Colorcon (E3P16), Kerry (E3F42), Sunhere (E3D46), and Well Pharmaceutical (E3D68), etc. to showcase innovative excipient products and technologies and share the application of excipients in different dosage forms. PharmaExcipients China 2020 will attract over 75,000 visits of professionals from around 140 countries and regions to have business talk and technical exchanges and locate partners.
Moreover, the organizer will concurrently explore the interpretation of Chinese and overseas policies and regulations, application and implementation of regulations, and technological innovation and R&D. Leaders and experts will be invited to analyze the latest industry policies and the excipient market trends and focus on how to boost the compliance and internationalization of formulations through excipient quality and technology upgrading.
China has paid more attention to the excipient industry in recent years while developing the API industry on a large scale. Except related policies and industry standards, it is strengthening regulations over pharmaceutical products and excipients and raising excipient entry thresholds to drive enterprises to improve innovation and technical levels, thus furthering market concentration and optimizing competitive environment.
Policies: Strict Requirements for Excipients to Gear to International Standards
The Opinions on Carrying out Quality and Efficacy Consistency Evaluation of Generic Drugs issued by the General Office of the State Council of China on Mar. 5, 2016 impels pharmaceutical enterprises to focus on quality stability and suppliers' regulated production when choosing excipients, and aims to boost China's excipient industry to transform and upgrade from low-end, bulk excipients to high-end, refined ones.
The Chinese Pharmacopoeia Commission issued on its website on Dec. 31, 2019 the Letter on Soliciting Opinions on the Rules for Drafting the National Standards for Pharmaceutical Excipients to make the excipient standards in the Chinese Pharmacopoeia more rigorous, regulated and operable, implement related provisions on excipient quality standards to point the way for Chinese excipient enterprises to improve their quality, and support the solution of key technical issues regarding excipients.
Enterprises: R&D Strength, Innovation Power and Import Substitution
New & complex excipients will be an important development direction of Chinese excipients as formulation R&D innovation and quality requirements are growing. However, the initial investment and risks are big due to Chinese excipient enterprises' long R&D cycle and slow R&D progress of new excipients. Limited by funds & technology, Chinese excipients are mostly in the low-end market, with simple processes, single products, low technical requirements, and fierce competition. Complex & new excipients are mostly produced by international large chemical enterprises with mature production technologies, such as DowDuPont, BASF, Wacker Chemie, Ashland, Arkema, and Evonik, etc., highly dependent on import. Therefore, the technical breakthroughs in Chinese excipients are a long-term, arduous task, and new excipient R&D has become the top driver of China's excipient industry.
PharmaExcipients China: Development, Cooperation and Trade Exchanges
The high-quality development of excipients in China is imperative in the context of developing high-end formulations. Only by developing new & complex excipients and improving excipient safety and quality can enterprises meet the current production requirements of formulations and promote the pharmaceutical industry to become increasingly high-end and international.
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