Overview:

On March 29, 2022, Hainan Boao Pilot Zone in China is soliciting neurological innovative products from global companies for Hainan Special Access. With Hainan health agency approval, the sponsor will receive special registration access and product launch. 

Introduction

The program is to encourage innovative medicinal product accessibility to Chinese patients in Hainan pilot zone first and fulfil huge unmet medical needs in neurological diseases across mainland China.

What are the Product Requirements?

  • Medicinal products or devices for the prevention and treatment of neurological diseases.
  • Marked abroad and not yet registered or marketed in China.
  • The product characteristics meets the advantages of clinical urgent needs, innovation, cutting-edge technology.

What are the criteria for submission of materials?

1- Product Information Sheet 

  • Information sheet on innovative drugs in neurology
  • Information sheet on innovative medical devices in neurology.

2- Product Introduction PDF( Foreign Language,Chinese Available)

What is the deadline for application?

The Application Period will be 29-Mar to 24-Apr-2022 *

*As of April 25th application has been extended for another two months

Questions on hainan baoa pilot zone ? GRP team is ready to help you!

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

References

 For the link, click here (Only available in Chinese).

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.

GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations. 

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