NMPA Registration of Pharmaceutical Packaging and Ingredients

Pharmaceutical Packaging and Ingredients

On 10.08.2016, NMPA initiated the combined registration of pharmaceutical packaging and ingredients together with pharmaceuticals (announcement no. 2016-134). If you would like to learn more about the specific regulations released since then, companies may request our *brochure *.

As part of the registration of pharmaceuticals, manufacturers must submit the DMF (Drug Master File) number of the pharmaceutical packaging and ingredients. Cisema can support the applicant during the preparation of the supplementary dossier and the second NMPA technical evaluation. We can help provide the required technical documents or test data in this supplementary phase.

According to NMPA regulations, foreign manufacturers of pharmaceutical packaging and ingredients shall appoint a NMPA Legal Agent for product registration.
Applicants who want to appoint a Chinese distributor as NMPA Legal Agent should be aware of the risks involved. Unfortunately, if your distributor does not hand over the DMF number to you, you lost your independence regarding product import and preventing you from changing distributors. What options you have when choosing the NMPA Legal Agent is explained in our * brochure *.

  • Are you a pharmaceutical manufacturer and need support with the supplementary dossier and second NMPA evaluation?
  • Are you a pharmaceutical packaging or ingredients manufacturer and require assistance attaining your DMF?
  • Would you like to know how much time and costs you should expect for the China NMPA registration?
  • Wondering how many test samples you need to provide to Chinese laboratories?
  • Are you unsure who to appoint as your NMPA Legal Agent and want to protect your independence?
  • Are you unsure if your ingredients are China compliant?
  • Do you have any concerns about revealing the exact manufacturing method and ingredients of your pharmaceutical product as part of the registration?
  • Do you worry about miscommunication with NMPA because of culture and language differences?
  • Are you afraid of failing the Chinese tests?
  • Wondering which application documents you have to submit?
  • Advice on applicable legislation and regulations
  • Determining whether your products need NMPA approval
  • Analysis of ingredients for compliance with Chinese regulations
  • Legal representation in China as NMPA Legal Agent for registration and regulatory affairs and protecting your independence
  • Application for China NMPA registration
  • Provision of complete document checklist and templates, including advice on the correct completion
  • Translations and notarizations
  • Provision of comprehensive test sample list
  • Close follow up of your sample tests in China
  • Communication and coordination between you and the Chinese authorities in technical and cultural terms
  • Follow-up support during the NMPA application of pharmaceuticals containing your packaging or ingredients

We are at your disposal

Contact

Do not hesitate to contact us if you have further questions or to request a non-binding offer.
You can contact us at +1 (0)773-449 5169 (US & Americas) or + 49 (0)89-4161 7389-00 (EU and worldwide) or via email.

To obtain further relevant information we recommend you
to visit our knowledge area or our registration page for exclusive information brochures.

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