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NMPA Issued the Announcement on the Requirements for Dossiers and Samples for Verification and Inspection of Specifications for Overseas New Drugs Urgently Needed in Clinical Settings
2019-07-18
NMPA organized the formulation of the Requirements for Dossiers and Samples for Verification and Inspection of Specifications for Overseas New Drugs Urgently Needed in Clinical Settings (Chemicals) and the Requirements for Dossiers and Samples for Verification and Inspection of Specifications for Overseas New Drugs Urgently Needed in Clinical Settings (Biologicals), which were issued on June 25, 2019.
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NMPA issued the Announcement on Implementing Electronic Application of Medical Device Registration
2019-07-06
NMPA has organized the development of the electronic Regulated Product Submission (eRPS) system, and announced the relevant issues on May 31, 2019
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NMPA Issued the Announcement on Issues Concerning the Import of Reference Drugs for Clinical Research of Biosimilar Drugs
2019-07-06
On November 30, 2018, NMPA issued the Announcement on Issues Pertaining to the One-off Import of Reference Drugs for Biologicals in Clinical Trials (Announcement No. 94 of 2018).
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SAMR Issued the Measures for the Administration of Imported Medicinal Materials
2019-07-06
The State Administration for Market Regulation (SAMR) issued the revised Measures for the Administration of Imported Medicinal Materials on May 16,2019.
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NMPA issued the Announcement on Adjusting the Relevant Matters Concerning the Definition of the Attributes of Drug/Device Combination Products
2019-07-06
To further standardize the definition of the attributes of Drug/Device Combination Products, according to the Three- Determinations (of posts, duties and staffing) regulations for NMPA institutions, on May 31, 2019, NMPA announced the relevant matters as follows.