Changing regulatory requirements in China
In 2019, China implemented an extensive overhaul of the regulatory requirements for drugs, resulting in a revised China Drug Administration Law, with an impact on domestic as well as foreign players in the Chinese pharmaceutical sphere. One of the consequences of this and subsequent changes to China pharmaceutical legislation, is that the NMPA (Chinese health authority) requires the submission of, and the pre-approval of, Drug Master Files (DMF) for ingredients and components of pharmaceutical (drug) products - including Active Pharmaceutical Ingredients (API), Excipients (EXC) and packaging materials. Existing products as well as new products are impacted.
As a result of the new requirement, ingredient manufacturers, such as Cargill, are required to prepare DMF dossiers for the individual components formulated into finished drug products. The dossiers are submitted to the CDE*, and based on a preliminary validation, CDE will issue a Filing number for the DMF. It is this Filing number that enables the downstream formulator of the finished Drug Product to submit their product registration dossier required for marketing authorization in China.
Therefore, the availability of the CDE filing number for the formulation components is a critical milestone in the timeline and regulatory strategy for companies seeking Marketing Authorisations for the finished Drug Product in China. As a supplier of ingredients used in drug products, Cargill has put a priority on fulfilling the requirement to submit DMFs to CDE and to obtain the necessary CDE Filing numbers required by our customers.
* Center for Drug Evaluation (CDE) is the body within NMPA, responsible for accepting submissions of DMF dossiers and their subsequent review and approval
Cargill confirms CDE filing for C✩PharmDex® & C✩PharmGel® in China
In cooperation with our entity in Beijing, Cargill’s European Manufacturing entities have submitted DMFs and received CDE filing numbers for key product lines including:
C✩PharmDex® 02010 dextrose monohydrate - Active Pharma Ingredient (API) for use as a carbohydrate source and osmotic agent in parenteral applications and oral preparations.
C✩PharmGel® 03406 & 03302 native maize starch - Excipients (EXC) for use as a binder, diluent or disintegrant in solid dosage forms. Typically used in oral preparations.
This enables our customers to meet the regulatory requirements for product registrations and also ensures minimal disruptions to supply of the Cargill products to the customers operating in China.
If you require any further assistance in accessing the DMF filing details and/or needing any further documentation, your dedicated Cargill contact is happy to help.
Through our active involvement with industry associations including amongst others, IPEC and APIC, and together with our customers and stakeholders, we will continue to follow the developments in China’s regulatory landscape.
Importantly, this will include closely monitoring evolving changes to Chinese pharmacopoeia, GMP requirements, etc that may have an impact on the products Cargill supplies to customers formulating for the China market.