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Juvederm’s Lip Filler, China’s First, Approved through Real-World Data Pathway

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Juvederm Volbella, indicated for lip enhancement, was approved by the NMPA on April 25, 2021. The clinical evaluation, conducted in Hainan utilizing Real-World Data methods, only enrolled 176 patients, according to their trial page at clinicaltrials.gov.

What’s the Device?

The Juvederm Volbella injectable gel is for injection into the lips for lip augmentation and for correction of perioral lines in adults over 21. It is the fifth product approved from Juvederm family and the first-of-its-kind filler for lip.

Juvederm Volux, its chin filler, has begun RWD in Hainan since July 2020. Click HERE for more information.

“Opinions on Certain Special Measures for Easier Market Access in Hainan”, issued on April 7, 2021, blueprinted the development of the aesthetics industry in Hainan. It states that world-renowned aesthetic clinics are to be allowed, which can use unapproved pharmaceuticals, medical devices, and cosmetics; authorities in Hainan will assist them to gain NMPA approval. Foreign aesthetic doctors and surgeons will practice there in short-term. International high-quality medical aesthetics resources, in respect of expos, conferences and regulatory standards, are to be converged.

With such a blockbuster product approved, RWD will draw more attention from big dermal filler companies, such as Q-Med, TEOXANE, MERZ, SUNEVA MEDICAL, and PROLLENIUM.

Urgent Use Policy & RWD

The foreign-approved devices for urgent Chinese clinical needs, without predicates approved in China, can be imported to Hainan via the policy dated back to April 2018. And then Real-World Data (RWD) of the imported device can be collected to support the regulatory approval from national NMPA.

Over the two years, over 100 medical devices and drugs have been imported to Hainan, including four represented by China Med Device.

China Med Device offers turnkey solutions to perform the feasibility assessment and also to obtain the real-world data approval for overseas manufacturers. info@ChinaMedDevice.com.

For our webinar on Hainan RWD program, please click HERE.

For the latest update from RWD program, please click HERE.

How to Obtain RWD?

The “Technical Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Trial Implementation)”, released on November 26, 2020, specifies the sources of RWD as following:

  • Data derived from electronic health records (EHRs)
  • Medical claims and billing data
  • Data from product and disease registries
  • Patient-generated data, including from in-home-use settings
  • Data gathered from other sources that can inform on health status, such as mobile devices.
  • Data generated from the complete life cycle of the medical device: production, sales, transportation, storage, installation, use, maintenance, decommissioning, and disposal. The data includes acceptance reports, maintenance reports, user feedback, use environment, calibration records, operation log, image raw data, etc.