Asia

Drug Master File (DMF) in China

Asia, blogs, China, Pharmaceuticals and Biologics, Resource Center / By

Since January 1, 2018, CFDA has not been accepting Active Pharmaceutical Ingredients (APIs), Pharmaceutical Excipients and Pharmaceutical Packaging Materials registration application independently. The Active Pharmaceutical Ingredients (APIs), Pharmaceutical Excipients and Pharmaceutical Packaging Materials are now reviewed/approved as part of a drug product application. Before called CFDA, now the National Medical Products Administration (NMPA) had a …

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Global Regulatory Partners

New Program for the Review of Innovative Medical Devices in China

Asia, blogs, China, Medical Devices, Regulatory / By

The Chinese National Medical Products Administration (NMPA) has published revised requirements for its innovative medical device review program that will take effect December 1, 2018. The new NMPA policy, Order 83 [2018] includes three major changes: Applications for Innovative Devices must be submitted to NMPA within five years of patent publications; Application review timeframes will …

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CFDA Announced Major Changes to Chinese Medical Device Regulations in favor of Foreign Manufacturers

Asia, blogs, China, Medical Devices, Regulatory, Resource Center / By

China Food and Drug Administration (CFDA) proposed major changes to medical device regulatory requirements by amending Order No. 650. The timeframe for the implementation of such changes has not been announced by CFDA yet, but foreign medical manufacturers are welcoming the new changes as they will address the major issues they are facing while registering …

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What our Clients say about Us

Thank you GRP team for registering our DMF in china. Your helped us achieve a big milestone for our company. The support and the commitment of your regulatory team have exceeded our expectations and made it easier for us to communicate with NMPA the Chinese authority. All the best !
Director of Regulatory Affairs Officer- CMC- A Large European Pharmaceutical Company based in Switzerland
We have been working with Global Regulatory Partners for 5 years and we consider them as our real partner and not as a consulting company, they had submitted 3 INDs for us with FDA successfully . The GRP team performs all IND amendments and annual reporting to FDA, we don’t have to worry about not being in compliance with FDA requirements at all.
CEO of Medium Size American Pharmaceutical Company operating in Nanotechnology based in USA
After submitting our drug application to NPMA ( Chinese FDA) , the Chinese agency requested us to conduct a local clinical study. Finding the qualified CRO for the study management in china was very challenging process because of the language barrier and the lack of understanding of GCP and ICH requirements. We finally found Global Regulatory Partners, that has a local team of professionals in regulatory and clinical affairs in china who not only conducted successfully our clinical study in china, but also helped us to understand the Chinese regulations related to our product.
CMO of Large European Pharmaceutical Company based in France and Operating in Radiopharmaceuticals
I am very impressed on how quickly Global Regulatory Affairs team was able to prepare and organize a face to face consultation meeting for our company with Anvisa in Brazil, The meeting was successful and helped us to validate and conform the regulatory strategy of our device registration in Brazil.
VP of Global Regulatory Affairs, American Based Medical device Company

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