scholarly journals AN OVERVIEW OF CHINESE DRUG REGULATORY SYSTEM: A REVIEW

2018 ◽  
Vol 2 (3) ◽  
pp. 14-18
Author(s):  
Ashok Kumar Nadipineni ◽  
Dileep K. G. ◽  
Ravindra C. K. ◽  
Suthakaran R.
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Regulatory System ◽  
International Standards ◽  
Chinese Drug ◽  
State Food ◽  
Drug Regulatory Authority ◽  
System A ◽  
Regulatory Standards ◽  
Regulatory Functions

The Drug regulatory authority of China was renewed from state pharmaceutical administration of China (SPAC) to state food and Drug administration (SFDA) with the announcement and declaration of Chinese ministry of health, the established regulatory standards of SFDA were keen to keep with international standards of EU, Japan and USA, the Drug registrations and Drug approvals are carried with established affiliated units for fast track evaluation within prescribed period ordered by SFDA, the state food and Drug administration is developed stringently and modified its standards according to the US healthcare regulatory system, in this review the permanently keeping standards of regulatory functions were detailed, and the untiring responsibilities of affiliated units of SFDA were to be recognized where their performance was a key aspect.

Dr Reddy’s Laboratories Ltd: Can It Be An Indian Pharma’s Bellwether Again?

2021 ◽  
pp. 097340822110313
Author(s):  
Rohit Kumar ◽  
Balaji Abraham
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Secondary Data ◽  
New Product ◽  
Data Sources ◽  
Growth Strategies ◽  
Success Stories ◽  
Indian Context ◽  
Regulatory Standards ◽  
Secondary Data Sources

Dr Reddy’s Laboratories Ltd (DRL) was one of India’s success stories in the pharma space, wherein a founder’s dream turned into a reality. It had a remarkable growth over three decades, with impeccable quality and regulatory standards, as it went on to become the number-two pharma company in India by sales. However, in the last 3 years, DRL was navigating one of the most challenging times it had ever faced for various reasons. Sales were stagnated, profits had plunged, costs had spiralled and manufacturing sites grappled with US Food and Drug Administration (FDA) issues—and more importantly, its growth strategies were not delivering results. This resulted in value erosion, reduced number of new product approvals, customers doubting the capabilities, competitors doing much better, etc. Also, it questioned whether DRL continued to be the bellwether or not for the Indian pharma fraternity as competitors raced ahead. This case highlights the global and Indian context of the pharma industry, along with details of three main competitors based on secondary data sources, and analyses the ongoing issues in DRL. Finally, it concludes by highlighting the six decision buckets and the way forward to make DRL a bellwether again in the Indian pharma industry.

Neurosurgical materials and devices

1976 ◽  
Vol 45 (3) ◽  
pp. 251-258 ◽  
Author(s):  
Charles V. Burton ◽  
Joseph T. McFadden
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
International Standards ◽  
Current Status ◽  
Reference Source ◽  
Legal Authority ◽  
Content Type ◽  
Fine Print

✓ The current status of voluntary consensus standards writing procedures in neurosurgery and the current progress of government efforts to regulate materials and devices are described. A survey of the national and international standards writing bodies is presented, along with an introduction to related organizations and agencies and nomenclature. The intent of this review is to provide the neurosurgeon with a reference source regarding past and present neurosurgical activities in the materials and devices field. When President Ford signed the 1976 Medical Device Amendments on May 28, 1976, the Food and Drug Administration assumed direct legal authority to control medical devices and potentially assumed the power to regulate those professionals using them.

scholarly journals Exploration on the safety assessment of nanomaterials in China

2012 ◽  
Vol 2 (3) ◽  
pp. 387-392 ◽  
Author(s):  
Xin-Li Shi ◽  
Qiangbin Wang ◽  
Kun Hu ◽  
Xiu-Mei Wang
Keyword(s):  
Drug Administration ◽  
Safety Assessment ◽  
Food And Drug Administration ◽  
Bone Grafts ◽  
The State ◽  
Chinese Market ◽  
Paper Briefly ◽  
State Food ◽  
Critical Challenge

More and more applications of nanomaterials have been achieved in the biomedicine field. Numerous nanomedical devices, such as bone grafts with nano-hydroxyapatite and the silver-based anti-bacteria products, have been developed and have been trying to enter into the Chinese market. The State Food and Drug Administration of China (SFDA) is facing a critical challenge of how to explore and supervise the safety assessment of the nanomedical products. This paper briefly introduces the approval status of nanomedical products and the current advances of the safety assessment of nanomaterials in China.

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