In our previous blog post, we discussed the new Drug Registration Management Measures that were recently announced by the Chinese FDA. In this second part of our series, we will further discuss the related review and approval system, and how it affects the pharmaceutical industry.
One of the key features of the new measures is the requirement for related review and approval of chemical raw materials, excipients, packaging materials, and containers used in the registration of drug formulations. The focus is on the quality of formulations and their ingredients, with primary responsibility falling on the holder of the market authorization. This is meant to facilitate the selection of high-quality ingredients and packaging materials for drug formulations.
The Drug Registration Management Measures also require chemical raw material and excipient manufacturers as well as packaging material and container manufacturers to register their products on the registration platform and provide relevant research data. The China National Medical Products Administration (NMPA) will then publish product information, as well as the registration numbers, product names, manufacturer names, and production addresses, on the platform, which facilitates the selection of appropriate ingredients and packaging materials for pharmaceutical companies. This provides a new opportunity for manufacturers of raw materials, excipients, packaging materials, and containers to expand their business.
It is important to note that registering ingredients and packaging materials on the platform is not mandatory, but it does provide manufacturers with the added benefit of showcasing their products to pharmaceutical companies. If the quality of the product is high, and it passes the related review and approval, the registration status will be updated, and more pharmaceutical companies will consider using it.
Pharmaceutical companies that choose to use unregistered ingredients and packaging materials must provide research data when registering their drug formulations. If the related review and approval is passed, the registration status of the raw materials, excipients, packaging materials, and containers will be updated, and the associated drug formulations can be approved for market authorization. If not, the registration status of the ingredients and packaging materials will remain unchanged, and the related drug formulations will not be approved.
For chemical raw materials, upon passing the relevant review and approval process, manufacturers will receive a conditional approval notice and the approved production processes, quality standards, and labels will be detailed in the notice. The conditional approval notice will contain the registration number of the chemical raw materials.
In conclusion, the new Drug Registration Management Measures are meant to improve the quality and safety of drug formulations by implementing related review and approval of ingredients and packaging materials. This will ultimately benefit the market and the pharmaceutical industry by ensuring that high-quality ingredients and packaging materials are selected, and avoiding the use of substandard materials.