China Drug Master File (DMF)
Excipients Exemption List
Did you know that certain pharmaceutical excipients are exempt from Drug Master File (DMF) registration in China?
The Chinese regulatory authority, the National Medical Products Administration (NMPA), has released a DMF registration exemption list for excipients. The China DMF exemption list includes excipients that are most commonly in pharmaceutical drug products which are considered by the CHinese health authorities as safe and low-risk.
An overview of China DMF Excipient exemption list
The China DMF exemption list for excipients is periodically updated by China NMPA. It includes a wide range of excipient categories, such as:
- Flavors
- Essences
- Pigments
- pH regulators and others.
The list also specifies the pre-conditions under which these excipients are exempt from DMF registration in China.
Principles for DMF exemption in China
To qualify for DMF exemption in China, an excipient must meet certain criteria, such as having a long history of use in pharmaceuticals or food industry, being widely accepted in the industry, and being safe and low-risk. The NMPA evaluates each excipient on a case-by-case basis before granting exemption.
China DMF Exemption List
Your excipeient may not require China DMF registration if listed in the following exemption list table:
| 1. | Flavoring agents (sweeteners): such as sucrose, monosaccharide syrup, xylitol, sorbitol, sodium saccharin, aspartame, sucralose, stevioside, glucose, mannitol, maltitol, etc. These products are only allowed to be used as flavoring agents (sweeteners) in formulations. |
| 2. | Flavorings and spices: such as orange flavoring, banana flavoring, coumarin, etc. For those subject to food standards, they should comply with relevant requirements such as GB 2760 “National Food Safety Standard: Food Additive Use Standard”, GB 30616 “National Food Safety Standard: Food Flavoring for Use in Foods” and GB 29938 “National Food Safety Standard: General Standard for Food Flavorings”. |
| 3. | Coloring agents: such as iron oxide, vegetable carbon black, cochineal red, etc. For those subject to food standards, they should comply with relevant requirements such as GB 2760 “National Food Safety Standard: Food Additive Use Standard”. |
| 4. | pH adjusters (including pH adjusters used in injection preparations): such as malic acid, fumaric acid, acetic acid, sodium acetate, citric acid (sodium, potassium salt), tartaric acid, sodium hydroxide, concentrated ammonia solution, hydrochloric acid, sulfuric acid, phosphoric acid, lactic acid, potassium dihydrogen phosphate, sodium dihydrogen phosphate, sodium hydrogen phosphate, etc. |
| 5. | Inorganic salts (including inorganic salts used in injection preparations) that are only used as excipients, have a simple preparation process, and have stable physicochemical properties: such as calcium carbonate, sodium carbonate, potassium chloride, calcium chloride, magnesium chloride, calcium phosphate, calcium hydrogen phosphate, calcium sulfate, sodium hydrogen carbonate, etc. |
| 6. | Benzene-free ink used for printing on oral preparations. |
The pharmaceutical excipients listed in the exemption list table above shall comply with the requirements of the current edition of the Chinese Pharmacopoeia.
For those excipeients not included in the current edition of the Chinese Pharmacopoeia, they should comply with the requirements of the National Food Standards or the current editions of the USP/National Formulary, European Pharmacopoeia, Japanese Pharmacopoeia, or British Pharmacopoeia standards. Other excipients should meet the requirements for pharmaceutical use.
*Note: If the listed excipients are used for purposes other than those indicated in this list, DMF registration in China is required according to the requirements or relevant materials should be provided in accordance with the requirements of drug evaluation.
Benefits of China DMF registration exemption
If your excipient is in the exemption list, manufacturers of excipient for marketing in China can save time and resources since DMF registration can be exempted. The exemption can save time and resources, speed up the product development and registration process and reduce costs. In addition, DMF exemption application is not required. The excipient dossier shall be directly included in the drug product application.
It is important to regularly check the China DMF registration exemption list for updates and changes to ensure compliance with Chinese regulatory requirements.
Is your excipient listed in the exemption list?
Accestra can support you to check whether your excipient qualifies for China DMF exemption. Please contact us for further details.
At Accestra, we have extensive experience in DMF registration in China. Our team of experts can help you navigate the regulatory landscape and ensure that your excipient products are registered correctly and efficiently. Contact us to learn more about our services and how we can help you with your China DMF registration needs.
Contact us now for support