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Leverage the role of “chain leader” in the biopharmaceutical industry chain and accelerate the clustering of biopharmaceutical enterprises.

Leverage the role of “chain leader” in the biopharmaceutical industry chain and accelerate the clustering of biopharmaceutical enterprises.

Xixian New Area Guorui Yinuo Drug Safety Evaluation and Research Co., Ltd. has been awarded the national drug GLP certification by the National Medical Products Administration, filling the gap in GLP laboratories in Shaanxi Province.

2020/11/10

Director Ying Hongfeng of the Provincial Drug Administration Bureau conducted a research visit to our province’s drug GLP certification institutions.

Director Ying Hongfeng of the Provincial Drug Administration Bureau conducted a research visit to our province’s drug GLP certification institutions.

Ying Hongfeng, Party Secretary and Director of the Provincial Drug Administration, along with a delegation of eight members, visited Guorui Yinuo Pharmaceutical Safety Evaluation Research Co., Ltd. in the Airport New City of Xixian New Area to inspect the construction of the company’s GLP laboratory for pharmaceuticals. Deputy Director Qi Huili, as well as relevant officials from the Registration Division, the Medical Device Division, and the Institute of Drug Control, and Zhai Riqiang, Party Secretary and Chairman of Shaanxi Pharmaceutical Group, also joined the inspection.

2020/11/10

Last year, China’s trade deficit in vascular stents was significant.

Last year, China’s trade deficit in vascular stents was significant.

There are a total of 53 companies in China engaged in the import of vascular stents, including 17 foreign-invested enterprises with an import value of US$248 million, accounting for 91.12%; 23 private enterprises with an import value of US$16 million, accounting for 6.04%; and 13 state-owned enterprises with an import value of US$8 million, accounting for 2.84%. In terms of quantity, private enterprises rank first; however, their share of the total import value is significantly lower than that of foreign-invested enterprises.

2020/11/10

Enforcement Q&A on Medical Device Manufacturing Addresses

Enforcement Q&A on Medical Device Manufacturing Addresses

In the registration management of medical devices, the manufacturing address is more critical than the registration address. According to the relevant provisions of the "Measures for the Registration Management of Medical Devices," if the registration address undergoes a substantial change, only a modification is required; however, if the manufacturing address undergoes a substantial change, re-registration is necessary. If the manufacturing address experiences only a textual change, only a modification is sufficient.

2020/11/10

Centralized procurement takes off—high-value medical devices may soon carry low-price labels.

Centralized procurement takes off—high-value medical devices may soon carry low-price labels.

In accordance with the requirements of six departments, including the Ministry of Health, high-value medical consumables such as vascular interventions, non-vascular interventions, orthopedic implants, neurosurgical devices, electrophysiological devices, pacemakers, extracorporeal circulation and blood purification devices, and ophthalmic materials will all be included in the scope of centralized bidding and procurement. Meanwhile, all public and non-profit medical institutions at the county level and above must participate fully in this centralized procurement.

2020/11/10

The Ministry of Health and five other departments jointly issued the "Guidelines for Centralized Procurement of High-Value Medical Consumables (Trial)."

The Ministry of Health and five other departments jointly issued the "Guidelines for Centralized Procurement of High-Value Medical Consumables (Trial)."

Procurement of high-value medical consumables across various regions suffers from issues such as low concentration, high procurement prices, significant price disparities among regions, heavy burdens on enterprises, frequent occurrences of improper practices in buying and selling, and irregular behavior by intermediary agencies. To standardize the procurement practices of high-value medical consumables in medical institutions, combat commercial bribery, and effectively reduce the financial burden of medical expenses on patients,

2020/11/10

Focus on institutional development and improve the regulatory framework for medical devices.

Focus on institutional development and improve the regulatory framework for medical devices.

The SFDA has actively promoted the revision of the "Regulations on the Supervision and Administration of Medical Devices," organizing and participating in numerous specialized meetings. It has also cooperated with the Legislative Affairs Office of the State Council to compile and analyze relevant feedback, actively engaged in inter-departmental coordination efforts, and made every effort to advance the revision process of the Regulations. Furthermore, in accordance with the principles set forth in the "Regulations (Third Draft for Comments by the Legislative Affairs Office)," the SFDA is advancing the formulation and revision of supporting regulations and normative documents, such as the "Measures for the Registration Management of Medical Devices."

2020/11/10

Urbanization unleashes grassroots demand, presenting opportunities for the medical device sector.

Urbanization unleashes grassroots demand, presenting opportunities for the medical device sector.

Although the “strong start” that many investors had been anticipating for the Year of the Snake did not materialize, the market’s pullback couldn’t stem the remarkable surge in the pharmaceutical sector. Last week, pharmaceutical stocks stood out on their own, with many companies within the sector even hitting all-time highs.

2020/11/10

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Xixian New Area Guorui Yinuo Drug Safety Evaluation and Research Co., Ltd.

Contact phone number

Ms. Li:+86 15760970681
Mr. Su:+86 19991001701
Landline:+86-29-33656828

Email

hr-xian@grglp.com

Company Address

4th Floor, Unit C. Building 9. Small and Medium-sized

Enterprise Park, Airport Industrial Zone Airport New Ciy,Xixian New Area, Shaanxi Province

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