Page 7 - THE SOUTH CHINA BUSINESS JOURNAL
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March 28, 2023, the Hainan government Moreover, in case the real-world data produced
issued new guidelines regarding the by these urgently required imported drugs and
administration of urgently needed imported medical devices satisfies the criteria for drug and
drugs and medical devices in the Boao Lecheng medical device registration and declaration in
International Medical Tourism Pilot Zone of the China, the applicants can include the data in their
Hainan Free Trade Port. application documents for national registration.
The Regulations on the Administration of Application and approval process
Urgently Needed Imported Drugs and Medical
Devices in the Boao Lecheng International The application and approval process for
Medical Tourism Pilot Zone of Hainan Free Trade urgently needed imported medical products in
Port, which will come into effect on May 1, 2023, Hainan involves several steps and requirements
will allow overseas unapproved medical devices, outlined in the new regulations. First, the
in vitro diagnostics (IVDs), and drugs to be used designated medical institution must meet
in China – if they can get the status of ‘clinical specific criteria, such as holding a medical
urgency’ and cannot be replaced by already institution practicing license, having the
available alternatives. capabilities of a tertiary Grade A hospital, and
having professional departments suitable for
The new guidelines optimize existing policies the clinical use of urgently needed imported
that came into effect in 2019. The policy is a drugs and medical devices.
significant development for China’s medical
industry, as it allows overseas manufacturers The medical institution must also have
to sell and commercialize their products more protection measures and management
quickly. Additionally, it provides them with an systems in place for circulation, transportation,
opportunity to gather real-world data from and storage that meet the requirements of
China’s local clinical evidence to support national the clinical urgently needed imported drugs
registration approval. and medical devices being applied for. They
must establish a drug adverse reaction/event
This article discusses the new regulations, their monitoring organization, be equipped with
scope and application process, and the potential trained personnel to perform monitoring duties
impact on China’s medical industry. correctly, and have emergency response plans
and disposal capabilities for serious adverse
How does China classify urgently needed reactions/events.
imported drugs and medical devices?
Once a medical institution meets the criteria, it
As per China’s regulations, urgently needed can apply for a qualification assessment review
imported drugs and medical devices in the from the provincial health authority responsible
Boao Lecheng International Medical Tourism for evaluation. If approved, the medical
Pilot Zone (referred to as the ‘Pilot Zone’) are department or team that intends to use the
medications and medical devices imported by product must hold a valid practice license and
medical institutions in the Pilot Zone for clinical have sufficient knowledge of the product to use
emergencies. These drugs and devices have it correctly and reasonably.
been authorized for sale abroad but have not yet
received registration approval in China, or there The designated medical institution must then
are no equivalent products registered in China submit an application for use through the
that can be used as a substitute. Clinical Urgently Needed Imported Medical
Products Traceability Management Platform,
Importantly, these urgently needed imported ensuring that the application materials are legal,
drugs and medical devices must only be used for accurate, and traceable. The provincial drug
specific medical purposes in designated medical supervision and administration department
institutions. These institutions are responsible should complete the assessment within seven
for ensuring their safe use and bear the main working days of receiving the application.
responsibility for associated safety risks.
If the product meets the criteria,
Specifically, the Boao Lecheng International the provincial drug supervision and
Medical Tourism Pilot Zone Medical Products administration department will issue an
Administration Bureau (referred to as the administrative license within the prescribed
‘Lecheng Medical Products Administration time limit, including a review of the product’s
Bureau’) is responsible for supervising and overseas marketing status and any associated
managing the urgently needed imported drugs adverse reactions or events.
and medical devices in the Pilot Zone.
SOUTH CHINA BUSINESS JOURNAL 4
issued new guidelines regarding the by these urgently required imported drugs and
administration of urgently needed imported medical devices satisfies the criteria for drug and
drugs and medical devices in the Boao Lecheng medical device registration and declaration in
International Medical Tourism Pilot Zone of the China, the applicants can include the data in their
Hainan Free Trade Port. application documents for national registration.
The Regulations on the Administration of Application and approval process
Urgently Needed Imported Drugs and Medical
Devices in the Boao Lecheng International The application and approval process for
Medical Tourism Pilot Zone of Hainan Free Trade urgently needed imported medical products in
Port, which will come into effect on May 1, 2023, Hainan involves several steps and requirements
will allow overseas unapproved medical devices, outlined in the new regulations. First, the
in vitro diagnostics (IVDs), and drugs to be used designated medical institution must meet
in China – if they can get the status of ‘clinical specific criteria, such as holding a medical
urgency’ and cannot be replaced by already institution practicing license, having the
available alternatives. capabilities of a tertiary Grade A hospital, and
having professional departments suitable for
The new guidelines optimize existing policies the clinical use of urgently needed imported
that came into effect in 2019. The policy is a drugs and medical devices.
significant development for China’s medical
industry, as it allows overseas manufacturers The medical institution must also have
to sell and commercialize their products more protection measures and management
quickly. Additionally, it provides them with an systems in place for circulation, transportation,
opportunity to gather real-world data from and storage that meet the requirements of
China’s local clinical evidence to support national the clinical urgently needed imported drugs
registration approval. and medical devices being applied for. They
must establish a drug adverse reaction/event
This article discusses the new regulations, their monitoring organization, be equipped with
scope and application process, and the potential trained personnel to perform monitoring duties
impact on China’s medical industry. correctly, and have emergency response plans
and disposal capabilities for serious adverse
How does China classify urgently needed reactions/events.
imported drugs and medical devices?
Once a medical institution meets the criteria, it
As per China’s regulations, urgently needed can apply for a qualification assessment review
imported drugs and medical devices in the from the provincial health authority responsible
Boao Lecheng International Medical Tourism for evaluation. If approved, the medical
Pilot Zone (referred to as the ‘Pilot Zone’) are department or team that intends to use the
medications and medical devices imported by product must hold a valid practice license and
medical institutions in the Pilot Zone for clinical have sufficient knowledge of the product to use
emergencies. These drugs and devices have it correctly and reasonably.
been authorized for sale abroad but have not yet
received registration approval in China, or there The designated medical institution must then
are no equivalent products registered in China submit an application for use through the
that can be used as a substitute. Clinical Urgently Needed Imported Medical
Products Traceability Management Platform,
Importantly, these urgently needed imported ensuring that the application materials are legal,
drugs and medical devices must only be used for accurate, and traceable. The provincial drug
specific medical purposes in designated medical supervision and administration department
institutions. These institutions are responsible should complete the assessment within seven
for ensuring their safe use and bear the main working days of receiving the application.
responsibility for associated safety risks.
If the product meets the criteria,
Specifically, the Boao Lecheng International the provincial drug supervision and
Medical Tourism Pilot Zone Medical Products administration department will issue an
Administration Bureau (referred to as the administrative license within the prescribed
‘Lecheng Medical Products Administration time limit, including a review of the product’s
Bureau’) is responsible for supervising and overseas marketing status and any associated
managing the urgently needed imported drugs adverse reactions or events.
and medical devices in the Pilot Zone.
SOUTH CHINA BUSINESS JOURNAL 4
