With the Arrival of the Deadline, Small and Medium-sized Enterprises of Pharmaceutical Excipients are under Tremendous Pressure

The State Council of China issued the Opinions on the Reform of Review and Approval System for Drugs and Medical Devices (GF [2015] No. 44) in August 2015, explicitly proposing to implement related review of pharmaceutical products, and pharmaceutical packaging materials and pharmaceutical excipients, and change separate approval of pharmaceutical packaging materials and pharmaceutical excipients to review and approval thereof together with the review and approval of pharmaceutical product registration applications.

China Food and Drug Administration (CFDA) issued the Notice of CFDA on Matters Relating to the Related Review and Approval of Pharmaceutical Packaging Materials and Pharmaceutical Excipients with Pharmaceutical Products (No. 134 in 2016) (hereinafter referred to as the No. 134 Document) in August 2016, and then issued the Notice of CFDA on the Requirements for Application Data of Pharmaceutical Packaging Materials and Pharmaceutical Excipients (Interim) (No. 155 in 2016).

At the end of October 2017, in order to further regulate the nonproprietary naming of pharmaceutical excipients and complete name approval of pharmaceutical excipients in the related review and approval with pharmaceutical products, China drafted the Principle for Nonproprietary Naming of Pharmaceutical Excipients of China (Draft for Comment) (hereinafter referred to as the "Draft for Comment"), to solicit public opinions.

The Draft for Comment requires Chinese-produced pharmaceutical excipients to be submitted data to the food and drug administrations according to the new application data requirements before January 1, 2018.

This means that the registration of pharmaceutical excipients in China will be officially reformed to the related review and approval management mode from the separate review and approval (approval No. management). The pressure for the small pharmaceutical excipient manufacturers has been presumably great since January.

Pharmaceutical excipient means the excipients and additives used for the pharmaceutical production and prescription dispensing, and substances that have been reasonably assessed for safety and are included in pharmaceutical preparations besides the active ingredients. Besides bulking up, serving as carrier and increasing stability, pharmaceutical excipients also have important functions like solubilization, hydrotropy, and sustained release, and quality of excipients may directly affect quality, safety, and effectiveness of pharmaceutical products.

Pharmaceutical excipients were separate and scattered in the past, but now, the implementation of the new system will help manage pharmaceutical excipients and related preparations on the same platform, to thus improve technical requirements for pharmaceutical excipients, enhance quality of pharmaceutical products of China, promote the innovation and R&D of enterprises, and improve industrial R&D and production as well as regulation initiative.

According to information, the pharmaceutical excipient industry of China has been progressing, however, the proportion of Chinese pharmaceutical excipients in the entire pharmaceutical products is still low, generally considered to be about 3%-5%, because the Chinese pharmaceutical excipients started late with low overall level.

The pharmaceutical product quality and safety level will be largely improved in China with the gradual improvement of the related review and approval system and industry regulatory system for Chinese pharmaceutical excipients. After implementation of the related review, pharmaceutical excipients will be directly administered by the CFDA, and small and medium-sized enterprises will be prompted to improve survivability while confronted with the pressure.

According to an insider, especially the development of pharmaceutical product industrial production necessarily requires the technology, process, and quality of pharmaceutical excipient production to support therewith, while the slowing down of new drug R&D and shifting of drug R&D towards new dosage forms will prompt process, quality and variety of pharmaceutical excipients to rapidly improve.

Overall, the review and approval reform of Chinese pharmaceutical excipients is being gradually implemented, and Chinese excipients are developing. The pharmaceutical industry and relevant regulators must work hard together to further improve pharmaceutical excipient quality and timely perfect the regulatory measures, so as to form a perfect environment for the sustained and healthy development of excipient and preparation industries.
 

(Source: Zyzhan.com)
Link: Zyzhan.com, http://www.zyzhan.com/news/detail/70474.html

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