8 May

Global Pharma can accelerate commercial sales and registration in China through Real World Data

Hainan Boao Lecheng special zone is the first area in China where RWD can be widely used. The Lecheng Real World Study (RWS) pathway allows overseas drugs, medical devices, and IVDs with clinical urgency status, that have not been approved by the China NMPA, to be sold and used in real world clinical settings in the Hainan province, China.

Overseas manufacturers can apply for RWS to collect RWD as China local clinical evidence to support its national registration approval. This program significantly shortens timelines for overseas medical products to be commercialized faster on the Chinese market. Recently a Boston Scientific RWS registration took only four months from application to approval, for its Rezūm water vapor therapy equipment^1.

The RWS Pathway is available to “urgently needed imported drugs and medical devices” that have been approved for marketing overseas but are not yet approved in China, which cannot be replaced by already marketed drugs in China and are urgently needed for clinical use for patients receiving treatment in certain medical institutions in the Hainan Pilot Zone. The application for qualifying medicines and devices must be submitted by a licensed medical institution in the Hainan Pilot Zone. The medical institution must be a Class A / Level Three hospital, the top tier of hospital in China, and one with advanced medical technology and personnel to manage the risks associated with complex products and procedures. Government regulations support licensing to be granted within just 22 Working Days for urgently needed devices² .

How is RWD used by the NMPA?

RWD is used by the NMPA to support its decisions during the review of new drugs application, and support strategies for new drugs' research and development:

1. To Support New Drugs' Registration
2. To Support Decision about Indication Change to Approved Drugs
3. To Support Post-Marketing Studies / Phase 4 studies

Benefits of the Hainan Program for Global Pharma & Biotechs

• NMPA unapproved products can be used in Hainan in real world data clinical settings after urgent use approval.
• Overseas manufacturers can apply for RWS to collect RWD as China local clinical evidence to support its national registration approval.
• The approved products by Hainan can be used outside of Hainan throughout China. However, patient’ treatments need to be done in Hainan, follow-up can be done outside of Hainan and need to report and get approval by the Hainan MPA or HC.
• Generate revenue immediately while collecting RWD.
• Products can be sold directly to hospitals.

Save R&D Time and Money

Contact our local HiRO China team to learn more.

Cristina.Chang@harvestiro.com

Becky.Lu@harvestiro.com