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NMPA Registration of Pharmaceuticals, Packaging and Ingredients

NMPA Registration of Pharmaceuticals, Packaging and Ingredients

Drugs

The SAMR (State Administration for Market Regulation) and NMPA (National Medical Products Administration) - former CFDA (China Food and Drug Administration) - oversee the management and registration of drugs (pharmaceuticals), pharmaceutical products, medical devices, in-vitro diagnostics and cosmetics.

In China, drugs are divided into TCM (Traditional Chinese Medicine), chemical drugs, and biological products for classified management. A brief overview of chemicals and biologics are discussed below. If you would like to learn more, please request our brochure or contact a Cisema expert.

Chemical Drugs

The registration of chemical drugs is divided into three categories: innovative new chemical drugs, improved new chemical drugs, and generic drugs. The second classification criterion is whether and where the drug is marketed. The chemical drug registration includes therefore the following five classes in total:

Class 1

Innovative new chemical drug that is not marketed both domestically and abroad It refers to drug that contains new compound with clear structure and pharmacologic effects and demonstrates clear clinical values.

Class 2

Improved new chemical drug that is not marketed both domestically and abroad It refers to drug which has improved the structure, dosage form, prescription process, route of administration, and indications, etc. of the known active ingredients, and demonstrates obvious clinical advantages over the original drug varieties.

Class 3

Generic drug produced by Chinese applicants domestically by imitating the original drug which has been marketed overseas but not marketed in China. It should be consistent with the originator in terms of quality and therapeutic effect.

Class 4

Generic drug produced by Chinese applicants domestically by imitating the original drug which has been marketed in China. It should be consistent with the originator in terms of quality and therapeutic effect.

Class 5

Drug marketed overseas

5.1 Original and improved drug having been marketed overseas (Improved drugs should have obvious clinical advantages).

5.2 Generic drug having been marketed abroad.

Biologics

Biological products are preparations that use microorganisms, cells, animal or human-derived tissues, and body fluids as starting materials and are produced by biological techniques for the prevention, treatment, or diagnosis of human diseases. In order to standardize the registration and management of biological products, they are divided into preventive biological products, therapeutic biological products, and in-vitro diagnostic reagents managed as biological products. In addition, the registration procedure is further classified according to innovative biological products, improved biological products, and marketed biological products (including Biosimilars).

Class 1: Innovative vaccine

Class 2: Improved vaccine

Class 3: Vaccines already marketed within or outside China

Class 1: Innovative biological product

Class 2: Improved biological product

Class 3: Biological product already marketed within or outside China

Class 1: Innovative in-vitro diagnostic reagent

Class 2: In-vitro diagnostic reagent already marketed within or outside China

Drug Master File (DMF) for Active Pharmaceutical Ingredients (API), Packaging and Excipients

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.

What are the responsibilities of the NMPA Legal Agent?

Pre-market Registration: In view of the special characteristics of pharmaceutical products (including API, excipients and packaging), foreign manufacturer shall appoint a professional domestic registration agent for drug registration in compliance with Chinese regulations.

Post Market Surveillance: According to Drug Administration Law of the People's Republic of China (2019 version), China implements system of drug market license holder management, which to manage drug safety, effectiveness and quality of drug development and production, which is called full life cycle management of drug. If the license holder is a foreign manufacturer, the foreign manufacturer shall appoint a domestic legal agent for fulfillment of legal obligations and responsibilities related to the license (product).

Applicants who want to appoint a Chinese distributor as NMPA Legal Agent should be aware of the risks involved. Unfortunately, if your distributor is either lack of general knowledge of regulations and standard policies or not fully transparent to you, you may lose your independence regarding product import, preventing you from changing distributors. Your options when choosing the NMPA Legal Agent is explained in more detail in our brochure.

What concern do you have?

➤ 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?

With which services of Cisema can we support you?

➤ 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.

➤ Provide response proposal of technical reviews by CDE.

➤ Assist site inspection initiated by CDE & CFDI.

➤ Follow-up support during the NMPA application of pharmaceuticals containing API or Drug.

NMPA Registration of Pharmaceuticals, Packaging and Ingredients

NMPA Registration of Pharmaceuticals, Packaging and Ingredients

Drugs

Chemical Drugs

Biologics

Drug Master File (DMF) for Active Pharmaceutical Ingredients (API), Packaging and Excipients

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