What is the NMPA

The China Food and Drug Administration (CFDA), or the now National Medical Products Administration (NMPA), is the Chinese regulating body that oversees pharmaceuticals, medical devices, and cosmetics. Some of their tasks and responsibilities include:

  • To routinely check the safety of the products offered in the market
  • Create laws and regulations
  • Encourage new technological advancements
  • Manage and organize product standards, classification systems, the National Essential Medicine List, and the national essential medicine system
  • Regulate registration, develop registration system, and review marketing material
  • Quality management of products
  • Monitor and evaluate post market risk, and managing emergency responses
  • Create management qualification for licensed pharmacists, and supervise the registration
  • Guide supervision of inspections, and punish illegal activities involved during the registration or manufacturing processes
  • Participate in international discussions and development of regulations

The Reform

In 2015, China had begun the process of reforming their regulatory body to improve the process of registration, review, and communication. Before the change, when manufacturers submitted their registrations, they would have to wait months or even years to receive feedback. The regulation requirements were hard to understand, and the local standards, clinical data and testing did not meet global standards. After the reform, new classifications of chemical drug registration were created, there are more regulations and guidances, and new evaluation and priority review criteria available. For a more detailed list of changes, click here.

After joining the International Council for Harmonization (ICH) in 2017, China’s regulatory process had improved significantly, allowing for an easier, simpler, and more efficient system. More products are available in the market, and many are meeting international standards. They’ve also allowed for foreign clinical trials to be admitted, which eliminates the need to conduct these trials in China and lessens the wait time to get approved and distribute products to the public.

Registering a Medical Device

Before applying to register a medical device to the NMPA, the company must have completed research and development to ensure their product follows the safety and effectiveness requirements, and to prove that all the data is complete, accurate, and traceable. Any application send must be in Chinese, along with a copy of the original non-translated documents.

If a manufacturer is applying to register their imported/foreign device, it must be approved in their home country’s market before applying to China’s. If the product is approved in the home country, but is not registered as a medical device, the manufacturers must provide proof that their product is registered and approved for public use.

Along with the application, manufacturers have to send product technical requirements, where the information about performance, testing, safety, and quality control is documented. The NMPA will classify the product according to how risky it might be for public use. Class I as the least risk item, and Class III as the riskiest. Upon registering, Class II and Class III products shall be required to conduct testing, while Class I devices can submit their own self-testing reports.

Products that have to undergo clinical testing will have to follow the Good Clinical Practice (GCP) requirements. Class III products that pose risks during clinical trials will be approved or denied by the NMPA itself, not by any qualified clinical trial institution. If approved, NMPAsends out application documents to a technical evaluation institution for analysis. After that, if NMPA approves of the medical device, they shall give the manufacturer an Approval Letter for Clinical Trial of Medical Device. If the product is rejected, the NMPAwill list the reasons why.

After clinical testing, the NMPA will need to approve or reject the registration application. If they approve it, they once again forward the information to a technical evaluation institution for another analysis, which can take up to 90 days for Class III devices. After evaluation if the NMPAapproves the product, the manufacturer will be given a medical device registration certificate. If disapproved, the NMPA will explain why. The registration certificate is valid for five years.

Registering a Drug

Any foreign drug application will have to be approved by theNMPA, and the application must be in Chinese. Manufacturers will have to prove the safety, efficacy, and quality of the drugs, and are liable for any problems that may occur. The NMPA will conduct inspections on the production site, on non-clinical studies, and clinical trials to ensure that all the information provided is authentic and accurate.

Applicants will have to provide patent, formula, experimental data, and manufacturing information. If a patent is already owned by another company in China, the applicant has to submit a statement of non-infringement. There will be a pre-clinical study of the drug which will look into:

  • Drug synthetic processes
  • Extraction methods
  • Physical and chemical properties
  • Purity
  • Selection of dosage form
  • Screening of formula
  • Preparing processes
  • Testing methods
  • Quality specifications
  • Stability
  • Pharmacology
  • Toxicology
  • Animal pharmacokinetics

Clinical trials will be supervised by the drug regulatory department. The trials have four phases. In Phase I, they will evaluate the human tolerability to the drug. In Phase II, they will study the therapeutic effects of the drug using randomized blind testing. Next, in Phase III, they will confirm the effectiveness and safety of the drug on patients and analyze the benefits and risks. Lastly, in Phase IV, they study the therapeutic effectiveness of the drug on a larger population to further analyze any benefits or risks of the drug. After completing the trial, the applicant has to send the final trial report, a statistical analysis report, and its database to the NMPA.

The company can apply for a special review if they fit the criteria for it. During the application review, the registration classification and technical requirements cannot be changed. The NMPAwill gather pharmaceutical and medical personnel to review submitted information. After that, they conduct on-site inspections and take samples. If the NMPA approves of the application, the manufacturer will receive a New Drug Certificate. After approval, the NMPA will continue to monitor the drug for five years after it is released to the public to ensure safety.

How We Help

Understanding the NMPA is crucial if your company plans or is interested in expanding to the Chinese market. Every regulatory body has its own rules and requirements that may differ from other countries. The regulations your company follows and understands in the U.S. might not apply nor matter in China, and so being up-to-date on Chinese regulations is essential and beneficial.

RegDesk helps to provide all regulation and requirement information for over 100 markets. With our service, medical device and pharmaceutical companies have access to and understand these regulations. We monitor any NMPA policy changes to provide the latest regulation information so that companies do not spend countless hours searching through newsletters and databases. Instead of wasting time with research, companies gather the information presented on our platform, and prepare for the next step in their expansion process.

163 Comments

  1. Here are some links to websites that we link to mainly because we think they are really worth visiting.

    Reply
  2. Just beneath, are several entirely not associated web sites to ours, having said that, they may be certainly worth going over.

    Reply
  3. I have been browsing online more than 2 hours today, yet I never found any interesting article like
    yours. It is pretty worth enough for me. Personally, if all webmasters and bloggers made good content as you did, the internet will be a lot more useful than ever before.

    Reply
  4. This article could not be written any more clearly! Nice write up. I enjoyed your post. Thank you. It’s like you wrote the book on it or something.

    Reply
  5. Quality posts is the secret to invite the users to go to see the website, that’s what this website is providing.

    Reply
  6. I wanted to thank you for this great read!! I definitely loved every little bit of it. I’ve got you saved as a favorite to check out new things you post… https://digitalviews.soup.io/

    Reply
  7. Thank you for the good writeup. It in fact was once a enjoyment
    account it. Look complicated to far introduced agreeable from you!
    By the way, how could we keep in touch?

    Reply
  8. I enjoy looking through a post that can make men and women think. Also, many thanks for allowing for me to comment!

    Reply
  9. I really liked your article post.Thanks Again. Much obliged.

    Reply
  10. Robin Sharma Books In Telugu
    Science News Of 2018

    Reply
  11. Im grateful for the article post.Much thanks again. Will read on…

    Reply
  12. The facts talked about inside the article are a few of the ideal readily available

    Reply
  13. always a huge fan of linking to bloggers that I adore but dont get a lot of link really like from

    Reply
  14. we like to honor many other world wide web web-sites around the net, even though they arent linked to us, by linking to them. Beneath are some webpages worth checking out

    Reply
  15. Thanks-a-mundo for the article. Want more.

    Reply
  16. I have been looking everywhere for this! Great post! I really like your article. I have been looking everywhere for this!

    Reply
  17. I blog frequently and I truly appreciate your content. Your article has really peaked my interest. I am going to take a note of your website and keep checking for new details about once per week. I subscribed to your RSS feed as well.

    Reply
  18. Thanks a lot for the blog article. Want more.

    Reply
  19. we came across a cool site that you may delight in. Take a search if you want

    Reply
  20. Here is a great Weblog You might Locate Intriguing that we Encourage You

    Reply
  21. Fantastic blog.Really thank you! Cool.

    Reply
  22. Support the man born of prophecies Cuong Truong a.k.a. King of kings and Lord of lords 777 immortality smart contracts space coffins in space funeral homes.

    Reply
  23. Paper Towns Novel Horizon Science Academy Fax Number

    Review my web-site; book epub

    Reply
  24. I appreciate you sharing this article.Thanks Again. Awesome.

    Reply
  25. we like to honor several other world wide web sites around the internet, even when they arent linked to us, by linking to them. Underneath are some webpages worth checking out

    Reply
  26. Here are some links to web-sites that we link to due to the fact we think they may be worth visiting.

    Reply
  27. Brad Thor Scot Harvath Series Book Of Proverbs Tagalog Version

    Here is my web blog; pdf

    Reply
  28. Science Technology Youtube 12th Result Up Board 2019 Roll Number

    my web blog … pdf book

    Reply
  29. Bill Nye Science Guy Bones And Muscles Science Water On Earth

    My blog post best books

    Reply
  30. we like to honor numerous other web web pages on the internet, even when they arent linked to us, by linking to them. Under are some webpages really worth checking out

    Reply
  31. Here is a great Weblog You might Discover Intriguing that we Encourage You

    Reply
  32. we came across a cool website that you just may well take pleasure in. Take a appear if you want

    Reply
  33. I’m nnot that much of a online reader to bbe honesst but your blogs really
    nice, keep it up! I’ll go ahedad and bookmark your website to come back in the future.
    All the best

    Reply
  34. Although internet sites we backlink to beneath are considerably not connected to ours, we really feel they are essentially really worth a go through, so possess a look.

    Reply
  35. I really liked your blog post.Much thanks again. Much obliged.

    Reply
  36. I just stumbled upon your blog. Your article has proven useful to me. Thanks for writing this. Very nice post!

    Reply
  37. Very good article post.Thanks Again. Awesome.

    Reply
  38. Everyone loves what you guys tend to be up too.
    This type of clever work and exposure! Keep up the
    fantastic works guys I’ve included you guys to blogroll.

    Reply
  39. Muchos Gracias for your article post.Much thanks again. Will read on…

    Reply
  40. An intriguing discussion is worth comment. There’s no doubt that that you need to publish more about this subject, it might not be a taboo matter but typically folks don’t discuss such issues. To the next! Cheers!!

    Reply
  41. Hi there, I discovered your blog by means of Google
    while searching for a related matter, your web site came up, it seems
    to be great. I have bookmarked it in my google bookmarks.

    Hello there, simply became aware of your blog thru Google, and located that it is really informative.
    I am going to be careful for brussels. I’ll be grateful when you
    proceed this in future. A lot of folks will likely be benefited from your writing.
    Cheers!

    Reply
  42. Colleges That Change Lives Fair Nyc Aims College Fees

    Feel free to visit my website; book epub

    Reply
  43. I have learn a few just right stuff here. Definitely value bookmarking for revisiting.

    I surprise how a lot attempt you put to create this sort of wonderful informative website.

    Reply
  44. usually posts some quite fascinating stuff like this. If you are new to this site

    Reply
  45. here are some hyperlinks to internet sites that we link to since we assume they may be worth visiting

    Reply
  46. Leading Online Pharmacy – Contact us at +1 (917) 259-3352 for unbelievable rates, discount and offers on any medicine. Get it delivered free of cost at your door steps, call us today. Phone : +1 (917) 259-3352

    Reply
  47. just beneath, are various totally not related web pages to ours, on the other hand, they’re certainly really worth going over

    Reply
  48. Magnificent goods from you, man. I’ve be mindful your stuff prior to and you’re just too
    magnificent. I really like what you have got right here,
    really like what you’re saying and the way through
    which you assert it. You’re making it entertaining and you still
    care for to keep it sensible. I cant wait to read much more from you.

    This is really a terrific site.

    Reply
  49. I enjoyed reading this. Nice read. It’s like you wrote the book on it or something. I really enjoy your work!

    Reply
  50. It’s like you read my thoughts! Right on with this article , as always. Great post! This requires some bold action on your part.

    Reply
  51. Sites of interest we’ve a link to.

    Reply
  52. Full disclosure, I should tell you that I used to work in this field. You just changed my view point on more than a couple things. It’s like you read my thoughts! Nice website.

    Reply
  53. below youll discover the link to some web sites that we feel you should visit

    Reply
  54. just beneath, are quite a few absolutely not related websites to ours, nevertheless, they may be surely worth going over

    Reply
  55. just beneath, are many totally not related web sites to ours, having said that, they are certainly worth going over

    Reply
  56. check below, are some entirely unrelated internet websites to ours, however, they’re most trustworthy sources that we use

    Reply
  57. below youll obtain the link to some web sites that we consider you must visit

    Reply
  58. check beneath, are some entirely unrelated web-sites to ours, having said that, they’re most trustworthy sources that we use

    Reply
  59. This is very fascinating, You are an overly professional blogger.
    I have joined your feed and look forward to in search of extra of your great post.
    Additionally, I have shared your site in my social networks

    Reply
  60. Howdy very cool website!! Man .. Beautiful .. Superb .. I’ll bookmark your website and take the feeds additionally?
    I am happy to search out so many helpful information right
    here in the put up, we want develop extra techniques in this regard, thanks for
    sharing. . . . . .

    Reply
  61. We came across a cool internet site that you just could possibly get pleasure from. Take a appear when you want.

    Reply
  62. Very good blog article.Really looking forward to read more. Will read on…

    Reply
  63. usually posts some really fascinating stuff like this. If youre new to this site

    Reply
  64. I just want to mention I’m very new to blogging and actually enjoyed your website. Most likely I’m want to bookmark your site . You surely come with exceptional articles. Thank you for revealing your webpage.

    Reply
  65. Hi there friends, how is all, and what you
    would like to say about this piece of writing, in my view
    its truly remarkable for me.

    Reply
  66. The information and facts talked about inside the write-up are several of the most beneficial available.

    Reply
  67. Hey very nice site!! Man .. Excellent .. Superb ..
    I will bookmark your web site and take the feeds additionally?
    I am glad to find a lot of helpful info here within the publish,
    we’d like develop extra techniques on this regard, thanks for sharing.

    Reply
  68. Below youll obtain the link to some sites that we consider it is best to visit.

    Reply
  69. After looking over a number of the articles on your site,
    I honestly like your way of blogging. I saved it
    to my bookmark webpage list and will be checking back soon. Please visit my
    web site too and tell me your opinion.

    Reply
  70. Here are a few of the web-sites we advocate for our visitors.

    Reply
  71. Good day! I could have sworn I’ve visited this site before but after looking at a few of the posts I realized it’s new to me. Nonetheless, I’m definitely pleased I stumbled upon it and I’ll be book-marking it and checking back often!

    Reply
  72. Really informative blog article. Really Great.

    Reply
  73. Holt Literature And Language Arts Fifth Course Pdf The
    Five Dysfunctions Of A Team Book Summary

    Feel free to surf to my web blog – book epub; bxtkdzy.shoppy.pl,

    Reply
  74. An intriguing discussion deserves remark. I assume that you must compose much more on this topic, it could not be a forbidden subject but generally people are not nearly enough to speak on such subjects. To the following. Thanks

    Reply
  75. Hey, you?re the goto expert. Thanks for haingng out here.

    Reply
  76. Here are some of the websites we suggest for our visitors

    Reply
  77. we came across a cool website that you may take pleasure in. Take a look if you want

    Reply
  78. Here are a number of the internet sites we recommend for our visitors.

    Reply
  79. just beneath, are numerous absolutely not connected web sites to ours, having said that, they are surely worth going over

    Reply
  80. Journal Of Agricultural Science And Technology David Publishing Impact Factor Huck Finn King And Duke Satire

    Feel free to surf to my homepage; pdf book (anwllpn.shoppy.pl)

    Reply
  81. Great blog you’ve got here.. It’s difficult to find quality writing like yours nowadays. I honestly appreciate individuals like you! Take care!!

    Reply
  82. I cannot thank you enough for the blog article.Really looking forward to read more. Really Cool.

    Reply
  83. Below youll uncover the link to some web sites that we assume you must visit.

    Reply
  84. Here is a great Weblog You might Come across Fascinating that we encourage you to visit.

    Reply
  85. Leading Digital Marketing agency in India and Kolkata, Leading Web Design company. Providing web designing and Digital marketing services, Digital marketing course, and certification with an internship.

    Reply
  86. Hey just wanted to give you a quick heads up. The text in your post seem to be running off the screen in Ie. I’m not sure if this is a format issue or something to do with browser compatibility but I figured I’d post to let you know. The style and design look great though! Hope you get the issue resolved soon. Cheers

    Reply
  87. We stumbled over here different website and thought I might check things out. I like what I see so now i’m following you. Look forward to checking out your web page yet again.

    Reply
  88. I blog often and I really appreciate your information. This article has truly peaked my interest. I will take a note of your website and keep checking for new details about once a week. I subscribed to your RSS feed as well.

    Reply
  89. Write more, thats all I have to say. Literally, it seems as though you relied on the video to make your point. You definitely know what youre talking about, why waste your intelligence on just posting videos to your blog when you could be giving us something enlightening to read?

    Reply
  90. Very couple of websites that occur to become comprehensive below, from our point of view are undoubtedly effectively really worth checking out.

    Reply
  91. Eleanor Und Park Film The Turn Of The Key What Happened To Rachel

    Also visit my webpage: pdf book

    Reply
  92. You made some really good points there. I looked on the net to find out more about the issue and found most individuals will go along with your views on this web site.

    Reply
  93. bookmarked!!, I like your website!

    Reply
  94. always a big fan of linking to bloggers that I like but really don’t get lots of link enjoy from

    Reply
  95. Thanks a lot for the blog post.Really looking forward to read more. Want more.

    Reply
  96. We came across a cool internet site that you may well get pleasure from. Take a search when you want.

    Reply
  97. I truly appreciate this post.Really thank you! Really Great.

    Reply
  98. Anula Vidyalaya Science Day 2019 True Grit Book Wikipedia

    Also visit my webpage: best books

    Reply
  99. I used to be able to find good advice from your content.

    Reply
  100. we like to honor several other world-wide-web web-sites around the web, even when they arent linked to us, by linking to them. Beneath are some webpages worth checking out

    Reply
  101. What Was The First Gothic Novel And When Was It Published
    Science Rocket Guy

    Also visit my website :: pdf

    Reply
  102. Sites of interest we’ve a link to

    Reply
  103. although sites we backlink to below are considerably not associated to ours, we feel they may be in fact really worth a go by, so have a look

    Reply
  104. It’s like you wrote the book on it or something. Nice write up. I enjoyed reading this. I enjoyed your post. Thank you.

    Reply
  105. I am typically to blog writing as well as i truly value your web content. The short article has truly peaks my passion. I am mosting likely to bookmark your website and maintain looking for brand-new info.

    Reply
  106. [ SEO – BACKLİNK – HACKLİNK – BLACK OR WHİTE HAT ]
    – – – – – – – – – – – – – – – –

    1- Senin için yorum backlink yapabilirim.

    2- I can comment backlink for you.

    3- Ich kann den Backlink für Sie kommentieren.

    4- Я могу прокомментировать обратную ссылку для вас.

    [ SEO – BACKLİNK – HACKLİNK – BLACK OR WHİTE HAT ]

    – – – – – – – – – – – – – – – –

    WhatsApp = +9 0422 606 06 30
    Mail = Seo.Backlink.44@gmail.com

    Google Search = Seo Bayi
    seo

    Reply
  107. Winnie The Witch St James Ny Jim Butcher Facebook

    Feel free to visit my page: ebook

    Reply
  108. A fascinating discussion deserves comment. I believe that you ought to compose extra on this topic, it may not be a forbidden topic however generally people are not nearly enough to speak on such subjects. To the next. Thanks

    Reply
  109. Aw, he did this quite a good post. In thought I wish to placed in writing such as this moreover C spending time and actual effort to produce a good article but exactly what can I say I procrastinate alot and never ever could have one thing done.

    Reply
  110. I am the co-founder of JustCBD company (justcbdstore.com) and am trying to broaden my wholesale side of business. I really hope that anybody at targetdomain can help me 🙂 I thought that the best way to accomplish this would be to reach out to vape shops and cbd retail stores. I was hoping if anyone could recommend a reliable web site where I can purchase CBD Shops Business Mailing List I am already looking at creativebeartech.com, theeliquidboutique.co.uk and wowitloveithaveit.com. On the fence which one would be the best solution and would appreciate any support on this. Or would it be simpler for me to scrape my own leads? Suggestions?

    Reply
  111. you have a great blog site here! would certainly you such as to make some invite messages on my blog site?

    Reply
  112. Greetings! Very useful advice in this particular post! It is the little changes that produce the most significant changes. Many thanks for sharing!

    Reply
  113. I have been looking everywhere for this! I really hope you’re making a lot of money off your site. Interesting content. I really like your article.

    Reply
  114. This website is really a walk-through for every one of the details you desired regarding this and also didn?t recognize that to ask. Glance here, as well as you?ll certainly find it.

    Reply
  115. Ever traveled to North Dakota? Thumbs up! You must really have a good head resting on your shoulders. Nice write up.

    Reply
  116. Good post. I learn something new and challenging on websites I stumbleupon every day. It will always be helpful to read through articles from other authors and use something from their sites.

    Reply

Submit a Comment

Your email address will not be published. Required fields are marked *