EXPEDIATED MARKET ACCESS TO CHINA THROUGH HAINAN BOAO HOPE CITY
GRP's Special program for Accelerated Market Access to China is offered to Foreign Pharmaceutical, Biotech and MedTech companies that have innovative products that are already approved in USA and/or EU or Japan.
- Earlier access to China mainland patients
- Earlier interaction between patients and KOLs
- Earlier collection of RWE for CDE registrations
AMTD & GRP Partnership
On May 2022, GRP China signed a partnership with AMTD Agency that manages the Hainan Special Access Program at Hainan province. Hainan
Special Access Program is offered to foreign pharmaceutical, biotech and MedTech companies that have innovative products that are already approved in USA and/or EU or Japan, and that are not registered in China or have similar products registered in China .
Hainan Boao Hope City Pilot Zone Plan
On April 8, 2021, with the consent of the Central Committee of the Party and the State Council, the National Development and Reform Commission and the Ministry of Commerce held a special press conference to publicly issue the Opinions on Several Special Measures to Support the Construction of Hainan Free Trade Port to Relax Market Access.
The pilot zone is located in Boao City, Hainan Province, located on an island in the South China Sea West of Hong Kong.
The zone is a controlled area of 25.89 square kilometers, with a planning range of 20.14 square kilometers, including 18.7 square kilometers on the north bank of the Wanquan River and 1.44 square kilometers for Le Island. The purpose of this controlled area is outlined in the ” Nine Articles Policy”.
What are the Main Advantages of Hainan Program?
1.0 Registration Approval in months Vs years
Usual registration timeslines in China range from 2-3 years.
Hainan program can expediate the process to 3 months
2.0 Reduced NMPA Review timelines
Priority review reduced from 200 to 130 working days in mainland china
3.0 Accelerated access to the makert
Sponsors and Manufacturers can sell products to Hainan hospitals after receiving approval
Reduced tariff for products importation to Hainan province
4.0 Expediated access to clinical studies
Collection of RWE on products as supplemental
Global Regulatory Partners services in Hainan
| Service Items | Hainan Special Access Only | Hainan + Mainland China Access |
|---|---|---|
|
Feasibility study |
Yes |
Yes |
|
Product registration at Hainan |
Yes |
Yes |
|
Product importation and distribution at Hainan |
Yes |
Yes |
|
Collection of RWE |
No |
Yes |
|
Product registration with NMPA |
No |
Yes |
Prequalification for Hainan program:
- Are you a foreign pharmaceutical , biotech and medical device companies with no local presence in China ?
- Do you have an innovative product already registered in USA, EU, Japan or Canada ?
- Are there no reference products or similar products already registered in China market?