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Related to the implementation of the pilot "first order" of the joint regulatory innovatio

2023-01-06

Haikou Customs announced on the 4th that 2750 key materials for biomedical research and development arrived at Haikou Meilan International Airport from Paris, France, and were released after on-site inspection by Haikou Meilan Airport Customs affiliated to Haikou Customs. This is the "first order" goods declared for import since the pilot of Hainan's joint regulatory innovation mechanism for the import of biomedical research and development goods, This marks the official landing of the pilot project of the joint regulatory innovation mechanism for the import of biomedical research and development articles in Hainan Free Trade Port.

It is reported that this batch of key materials for pharmaceutical research and development are imported by Qilu Pharmaceutical (Hainan) Co., Ltd. and will be used for the research and development of a sub project of the national major scientific research project undertaken by the company.

The Pilot Work Plan of Hainan Biomedical R&D Articles Import Joint Supervision and Innovation Mechanism (hereinafter referred to as the "Plan") is formulated in the form of "small incision" by taking the high-quality development of Hainan Free Trade Port's biomedical industry as the background, taking the initiative to benchmark international and domestic advanced experience, using Hainan Free Trade Port's policy of first trial.

The Plan stipulates that a list of pilot enterprises and a list of research and development articles shall be established, a biosafety risk assessment team shall be established, and a joint risk assessment shall be carried out for the research and development articles to be imported from the list. The enterprises shall apply to the customs for the approval of entry-exit special goods for health inspection and epidemic disease by virtue of the joint risk assessment report, and at the same time apply to the Hainan Food and Drug Administration for relevant certification materials, With the approval form of customs entry and exit health quarantine of special goods and the certification materials of Hainan Food and Drug Administration, the enterprise does not need to apply to Hainan Food and Drug Administration for the Customs Clearance Form of Imported Drugs. This has solved the problem that Hainan biomedical enterprises cannot obtain the drug clearance form for the imported R&D articles in international trade, and strengthened the safety supervision measures for R&D articles, which is conducive to preventing biological security risks.

In order to promote the smooth implementation of the project, Haikou Customs has set up a special working class, discussed with local relevant departments for many times, promoted the issuance of the Plan, and actively built a multi sectoral joint supervision mechanism. Work together with Haikou Municipal People's Government to formulate the operational procedures for risk assessment of Haikou's entry-exit special goods, and establish a team of risk assessment experts including Haikou Customs, Hainan Drug Administration, Hainan Health Commission, Hainan Institute for Drug Control, Hainan Center for Disease Control and Prevention, Hainan Medical College, Hainan University and other units, Guide Haikou National High tech Industrial Development Zone to conduct the first joint risk assessment on Qilu Pharmaceutical (Hainan) Co., Ltd., guide international trade enterprises to complete product filing and health quarantine approval of special goods, do a good job in customs clearance guarantee, and ensure the smooth landing of the pilot "first order".

In the next step, Haikou Customs will continue to further explore and optimize the regulatory process, expand the scope of risk assessment, help international trade enterprises make full use of the policy dividend of Hainan Free Trade Port, and promote the high-quality development of Hainan's bio pharmaceutical industry.


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