China NMPA (National Medical Product Administration) Registration
The People's Republic of China is the fastest
growing market for health and beauty products in the world and offers huge
commercial potential for international manufacturers of medical devices,
pharmaceuticals and cosmetics.
Entering the Chinese market can be challenging due to complex regulations, language barriers and intense competition.
Cisema has handled hundreds of projects and can help you meet China's NMPA requirements.
What is Chinese NMPA registration?
It is the registration procedure
of China's NMPA (National Medical Products Administration, formerly CFDA -
China Food and Drug Administration), in which the following product categories
are certified according to the guidelines:
pharmaceutical packaging and ingredients
► Medical devices (including IVDs)
► Breast milk substitute
► Food for special medical purposes
► Healthy food (food
supplements and food products with special health functions)
In light of globalization, increasing international competition, and efforts to harmonize with other international standards, Chinese legislation introduced the approval of NMPA after opportunity identification into the system.
Import, trade and use of the above products can only be done after obtaining a valid NMPA registration to ensure the quality and safety of the products.
What are the most important areas of responsibility of the State Pharmaceutical Administration?
Safety supervision of drugs (including traditional Chinese medicine, ethnic
medicine, same as below), medical device and cosmetics supervision.
regulatory policy plans, organizes the development of regulatory acts, develops
regulatory documents and supervises their implementation.
and formulation of foreign drugs, medical devices and cosmetics Monitoring and
support policy for new technologies and new products.
(2) Perform standard management of drugs, medical devices and cosmetics; organizes
the compilation and issuance of "Chinese Pharmacopoeia" and other
drug and medical device standards, organizes the preparation of cosmetic
standards, organizes the formulation of classification management systems and
supervises their implementation, participates in the creation of the national
essential drugs list, assists in the implementation of the national essential
Regulates the registration of medicines, medical devices and cosmetics.
Formulate the registration system, strictly approve the list, improve the
promotion of approval and organize the implementation.
(4) Perform quality control of medicines, medical devices and cosmetics; formulates good laboratory practice (GLP) and good clinical practice (GCP) and monitors their implementation.
Under the NMPA's duty to formulate good manufacturing
practices (GMPs) and monitor their implementation, to develop good practices
for the distribution and use of medical devices and to drive their
(5) Taking care of post-marketing risk management of drugs, medical devices and cosmetics, organizes the monitoring, evaluation and management of side effects of drugs, adverse events of medical devices and adverse effects of cosmetic products.
In accordance with the law to act in emergency situations with
medicines, medical equipment and cosmetics.
Engages in the administration of the qualification of licensed pharmacists,
formulates regulations on the qualifications of licensed pharmacists and
directs and supervises the registration of licensed pharmacists.
(7) Organizes and directs the supervision and inspection of medicines, medical devices and cosmetics.
To establish an inspection system to investigate and
deal with illegal activities in the registration process of drugs, medical
devices and cosmetics, and to organize and lead the investigation and
punishment of illegal activities in the production process in accordance with
the duties of the Food and Drug Administration.
Carry out international exchange and cooperation in the supervision of
medicines, medical devices and cosmetics and participate in the development of
relevant international supervision rules and standards.
To direct the work of all drug control and administration departments of
provinces, autonomous regions and municipalities directly under the central
To carry out other tasks assigned by the party's Central Committee and the
What are the regulations for NMPA registration in China?
Not only for first-time applicants, but also for business veterans, changes in legislation and expanded legal requirements can lengthen the registration process. This is because the NMPA legislation for the approval of certain product groups has only recently been introduced and therefore needs to be constantly reassessed.
What are NMPA Registration Management Rules?
standard (national standard, "national standard" in Chinese) and
Standard ("Industry Standard" from TCM-Traditional Chinese Medicine)
Similarities with international (EU, USA, etc.) standards. However, these guidelines have been supplemented with China-specific requirements.
Previously achieved ISO standards may assist in the registration process, but are not required.
Businesses can obtain more information about NMPA regulations and legal requirements by requesting our brochure.
What is the Chinese State Food and Drug Administration?
Over the years, the structure and name of China's
Life Science Product Regulatory Authority have changed several times. It is
called SDA (State Drug Administration), SFDA (State Food and Drug
Administration) and CFDA (China Food and Drug Administration).
On March 13, 2018, during the 13th National People's Congress, the Chinese Cabinet decided to rename CFDA to NMPA (National Medical Products Administration).
During this conference, the number of ministerial departments was also reduced and SAMR (National Market Regulation Administration) was established to oversee NMPA, AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine) and SAIC (National Market Regulation Administration). Business).
The relevant regulations and the officials responsible for registration remain unchanged
On which date was CDFA replaced by NDMA?
On 1st September, 2018, the CFDA (China Federal Drug Administration) was replaced by the NMPA (National Medical Products Association).
China's State Food and Drug Administration (CFDA China, 国家药品监督管理局) renamed to National Medical Products Administration or NMPA China is Chinese government's administrative body responsible for regulating pharmaceuticals, medical devices and cosmetics in China.
Which Institutions are affiliated to NPMA China?
• National Institutes
for Food and Drug Control (Center for Medical Device Standards Management of
NMPA, National Institute for Drug Control)
• Center for Drug
Evaluation of NMPA
• Center for Food and
Drug Inspection of NMPA
• Center for Drug
Reevaluation of NMPA
• Center for Medical
Device Evaluation of NMPA
• Center for
Administrative Services and Complaints & Reports of NMPA
• Information Center
• NMPA Institute of
Executive Development (NMPA Safety Emergency Drill Center)
• Certification Center
for Licensed Pharmacist of NMPA
• News and Publicity
Center of NMPA
• China Center for
Food and Drug International Exchange
• Center for
Administration Service of NMPA (Administration Service Bureau of NMPA)
• NMPA Southern
Medicine Economic Research Institute
• 146 Warehouse of
• Chinese Pharmaceutical
• China Health-Media
Where can I get NPMA China registration form?
You may get NPMA China registration form from the link
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