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Latest Guidebook for Chinese Clinical Urgent Demand

This Report provides Review and approval procedures for the Chinese overseas imported new drugs with the duties and obligations of overseas pharmaceutical manufacturers.

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Latest Guidebook for Chinese Clinical Urgent Demand

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  1. Aarkstore Market Research

  2. Chinese drug approval and regulations procedure

  3. Summary Chinese Clinical Imported and Overseas New Drugs - Guidebook for Review and Approval Procedures, 2019 Edition This Report provides Review and approval procedures for the Chinese overseas imported new drugs with the duties and obligations of overseas pharmaceutical manufacturers. Review and approval procedures for the Chinese overseas imported new drugs, clinical urgent demand with selection process and scope of drug varieties.

  4. Market Summary The Chinese “National Medical Products Administration (NMPA)” and the “National Health Commission (NHC)” jointly issued the latest “Review and Approval Procedures of Overseas Imported New Drugs for Clinical Urgent Demand” on October 23, 2018, which provided a dedicated pathway for priority review and approval of overseas drugs importing to Chinese healthcare market and clarified the specific review and approval procedures. Undoubtedly the Chinese healthcare market of nearly 1.4 billion populations is a huge business opportunity for the overseas pharmaceutical manufacturers.

  5. Key Points • Introduces that review and approval procedures of overseas imported new drugs of Chinese clinical urgent demand are applicable to what scope of drug varieties.  • Expounds the selection process of drug varieties.  • Exhibits the first batch list of overseas imported new drugs of Chinese clinical urgent demand that has been selected by the Chinese drug regulatory authority • Expounds the duties and obligations of overseas pharmaceutical manufacturers for drugs exported to the Chinese healthcare market.  • Expounds the Chinese drug regulatory authority’s requirements for application materials that overseas applicants apply for overseas imported new drugs of Chinese clinical urgent demand. 

  6. Related Reports • Latest guidebook for Chinese Drug Recall Regulations (2014 Edition) • Latest Chinese Guidebook for Regulations on the Administration of Overseas Inspection for Imported Drugs and Medical Devices (2019 Edition) • Latest Chinese Guidebook for Medical Device Adverse Events Reporting, Monitoring and Re-Evaluation (2019 Edition)

  7. Thank You ! For More Details Please visit www.aarkstore.com +91 7710006788 | contact@aarkstore.com

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