China announces new fees, documents and samples now required for API DMFs in China

Earlier in March, the Chinese NMPA issued new regulations for API DMFs in China.  Now, DMF manufacturers need to pay the NMPA about $50,000 to get their APIs activated in China whereas there used to be no government fee.  Also, more documents are needed.

The following documents and samples are required to be provided to the China National Institutes for Food and Drug Control for drug registration inspections:

  • The Chinese and English quality specifications, analytical procedures and relevant production process document for the product (one hard copy and one electronic copy respectively)
  • Three batches of samples that have been marketed abroad or domestically and certificates of batch release, the quantity of each batch is the triple amount of full tests.
  • Standard substances (reference substances) and its CoA.

Also, samples need to be tested too. Sufficient samples and reference substances must be provided. It is suggested that the amount provided should be 10 times the amount needed to perform one full test.