On January 12, the National Medical Products Administration (NMPA) announced (No.6-2021) the amendment regulation (draft) for the registration of drug-device combination products.
The new draft refines the 2009 version with 8 major changes whilst the definition of drug-device combination products remains unchanged, the purpose of the changes is to clarify the registration requirements and categorization method of different drug-device combination products.
The new draft proposed to remove the following clause 6 from the original regulation:
“Applications for combination products, importing to China for the first time, will not be accepted for the following reasons:
– The market approval of the product has not been obtained from the exporting country
– The drug contained in the product has not obtained the registration approval from China or the market approval from the country of origin”
The draft also provided the following reasons for removing clause 6:
– Some of the drugs contained in the combination products may not be regulated in the exporting country hence it could be impossible to obtain the required marketing approval
– Even if the drug has obtained the marketing approval from the exporting country, the combination product may contain the raw material(s) of the drug with the adoption of a different production process, dosage, intended use etc. from the original drug itself
As a solution, applicants are suggested to refer to the following clause 2 (updated in the new draft) for submitting the appropriate market approval certificate:
– If the combination product intends to achieve a therapeutic effect on the patient, the applicant shall meet the registration requirements of a medical device in China. Otherwise, if the combination product intends to achieve a drug effect on the patient, the applicant shall meet the registration requirements of a drug product in China.
In addition, the NMPA will implement a new set of technical review guidelines soon for the applicants to follow when registering their products in future.
The NMPA launched a public consultation to solicit comments for the draft. Stay tuned for more updates and let us know if you would like to share your opinions with us before the consultation period ends on January 26, 2021.
By Jacky Li. Contact Cisema if you would like to learn more.