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NMPA approves oral formulation of Akynzeo in China biospectrumasia
September 25, 2019
Riccardo Braglia, Helsinn Group Vice Chairman and CEO commented: "Lack of control of CINV is a problem despite the availability of several antiemetics. We are pleased that Akynzeo® that targets two CINV critical pathways in a single dose will help patient
NMPA Issued the Notice on Expanding the Pilot of the Medical Device Registrant System chinadaily
August 21, 2019
As per the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Reform of Review & Approval System to Encourage Innovation in ...
NMPA Issued the Announcement on Issues Pertaining to the Implementation of Drug Standards in the Consistency Evaluation of the Quality and Efficacy of Generic Drugs chinadaily
August 21, 2019
To promote the consistency evaluation of the quality and efficacy of generic drugs, and clarify the relationship between the registration standards of generic drugs and the national drug standards such as the Pharmacopoeia of the People's Republic of Chin
NMPA issues notice on publicity and implementation of Vaccine Administration Law chinadaily
August 14, 2019
The National Medical Products Administration (NMPA) released a notice on the Vaccine Administration Law of the People's Republic of China on July 25, 2019, calling for study and implementation of various aspects of the law by relevant drug regulatory depa
NMPA launches English-language website NMPA
July 29, 2019
Tell China's drug regulatory stories to the world
NMPA issued the Announcement on Adjusting the Relevant Matters Concerning the Definition of the Attributes of Drug/Device Combination Products chinadaily
July 24, 2019
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 ...
A Review of MS drugs in China PharmaSources/Caicai
July 24, 2019
There are only two MS drugs approved for marketing in China, separately being the interferon beta-1a and teriflunomide...
NMPA Issued the Announcement on Issues Concerning the Import of Reference Drugs for Clinical Research of Biosimilar Drugs chinadaily
July 23, 2019
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), clarifying that the applicant can apply for ...
NMPA issued the Announcement on Implementing Electronic Application of Medical Device Registration chinadaily
July 23, 2019
To implement the relevant policies set forth in the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Reform of ...
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 chinadaily
July 23, 2019
To implement the requirements in the Announcement on Issues Pertaining to the Review and Approval of Overseas New Drugs Urgently Needed in Clinical Settings (No. 79 of 2018) and expedite the review & approval of ...

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