If you want to access China market faster as an overseas manufacturer, Hainan policy, the predecessor to the Guangdong-Hong Kong-Macao Greater Bay Area recent notice, should be evaluated as well. China is trying to shorten the approval time and allow its citizen to benefit from the latest approved drugs or devices from overseas while stimulating its innovation. Hainan policy allows China NMPA unapproved devices and drugs to be used in Hainan region if the device and drugs are needed in China and no predicates products have been approved in China. The "Guangdong-Hong Kong-Macao Greater Bay Area Drug and Medical Device Regulatory Innovation Development Project Plan" issued on November 25th, 2020 is the 2nd region that starting to allow overseas unapproved devices and drugs to be used in the region. The greater bay area is at its beginning of this new policy with only one approved hospital as the pilot to establish the process. On the other hand, Hainan is more matured in its detailed implementation guidance and process. 10 hospitals have been established and 17 more are up and coming including foreign owned hospitals. In addition, the key is the clinical data collected from these initial sold devices can be used to support clinical evidence in the final national regulatory approval as real-world evidence if it follows certain protocol. I was involved in the first pilot product launch meeting in Hainan Lecheng in October 2019. More than 100 drugs and devices have been approved and used in Hainan Lecheng. A subset has obtained fast track approval where you can obtain approval in months instead of years. We have been personally involved every step of the way.
RAPS has a webinar that I recently presented along with the Hainan Lecheng Bureau chief, Mr Gu and the NMPA RWD advisor, Professor Sun. If you need a copy of the PPT, please let me know. The link is at https://www.raps.org/events/webcast-fast-track-your-initial-clinical-use-with-the-hainan-rwds-pilot-program
I would love to hear your experiences if you participated in any of the programs with your devices. There will be a Real-world data discussion forum in Beijing on December 27th and 28th (no in-person meeting restrictions inside China). The meeting will have NMPA reviewers, key stake holders and manufacturers to attend to provide their feedback on their pilot experience and suggestions for real-world data.
Pain points usually means opportunity for improvements. Please do feel free to share your feedback. Collectively we will be more efficient.
Grace Fu Palma
------------------------------
Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------
Original Message:
Sent: 16-Dec-2020 03:54
From: Hamish King
Subject: China market access for MedTech via Hong Kong and the Greater Bay Area
Hi Venkata
Yes there is scope for combination products too.
Regards
Hamish
------------------------------
Hamish King
Director Business Development
Hong Kong
Original Message:
Sent: 15-Dec-2020 12:36
From: VENKATA NAGESWARA RAO
Subject: China market access for MedTech via Hong Kong and the Greater Bay Area
Hi Hamish,
Is this applicable for Devices only or any scope for combination products (Drug + Device),
Tq
------------------------------
VENKATA NAGESWARA RAO
Bangalore
India
Original Message:
Sent: 14-Dec-2020 21:10
From: Hamish King
Subject: China market access for MedTech via Hong Kong and the Greater Bay Area
There have been ongoing discussions between Hong Kong and Mainland about using Hong Kong listing as a shortcut to enable sales into China's Greater Bay Area, which has a population nearly the size of Germany. I wrote about it earlier this year here: Asia Pacific Biotech News (asiabiotech.com). There has been recent confirmation of the pilot programme from the Mainland side which takes another step to making the pathway a reality.
Hong Kong listing is voluntary (so often not done) but from a practical perspective is generally required to sell into Hong Kong public hospitals. The idea is that once your medical device is sold into Hong Kong public hospitals, you can then sell into Hong Kong-owned hospitals in the Greater Bay Area. Whilst still in pilot phase, it's an exciting prospect for global MedTech manufacturers.
If you're interested in exploring how this could work for you, please get in touch.
Regards
Hamish
Hamish King | LinkedIn
------------------------------
Hamish King
Director Business Development | Cisema
Hong Kong
hamish.king@cisema.com
------------------------------