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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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The 2018 Drug Review Annual Report released
2019-07-06
The 2018 Drug Review Annual Report was released on July 1,2019.
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CDE Released the List of the Second Batch of Overseas New Drugs Urgently Needed in Clinical Settings
2019-07-06
On May 29, 2019, NMPA Center for Drug Evaluation issued the Notice on the Issuance of the List of the Second Batch of Overseas New Drugs Urgently Needed in Clinical Settings.
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NMPA issued the Announcement on Adjusting the Relevant Matters Concerning the Definition of the Attributes of Drug/Device Combination Products
2019-05-31
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.
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NMPA Issued 3 Guidelines for Technical Review of the Registration of Synthetic Resin Teeth and Others
2019-05-22
To strengthen the supervision and guidance over the registration of medical device products and further improve the quality of registration review, NMPA organized the formulation of and published the Guidelines for Technical Review of the Registration of Synthetic Resin Teeth,the Guidelines for Technical Review of the Registration of IUD, and the Guidelines for Technical Review of the Registration of Implantable Drug Delivery System on May 22, 2019.
