Revision of the summary of product characteristic of anthroposophic preparations in parenteral dosage forms containing mistletoe – Result of a compromise between the marketing authorization holders and the German Federal Institute for Drugs and Medical Devices

Phytomedicine ◽  
2011 ◽  
Vol 18 ◽  
pp. S5
Author(s):  
C. Werner ◽  
M. Kirch ◽  
I. Spingler-Kliemsch ◽  
W. Knöss
Keyword(s):  
Medical Devices ◽  
Dosage Forms ◽  
Product Characteristic ◽  
Marketing Authorization ◽  
Federal Institute

scholarly journals Marketing authorization of medical devices in China

2016 ◽  
Vol 22 (1) ◽  
Author(s):  
Weifan Zhang ◽  
Rebecca Liu ◽  
Chris Chatwin
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Marketing Authorization ◽  
Regulatory Environment ◽  
Doing Business ◽  
The Us ◽  
Research Gap ◽  
Business In China ◽  
China’S Economy

Medical device regulations across the globe have significant variations. The Chinese medical device market, like China’s economy, is developing rapidly. This article reviews the medical device regulations in China and illustrates the major changes that have been recently implemented according to the new medical device regulations that came into force on the 1st June, 2014. Most regulatory research has focused on the US and EU medical device regulations with little written about the Chinese medical device regulations. The purpose of this article is to bridge the research gap and to introduce the Chinese medical devices regulatory environment to investors or companies who are engaged in the medical device market or doing business in China

scholarly journals REGULATIONS OF REGISTRATION AND IMPORT OF MEDICAL DEVICE IN INDIA

2018 ◽  
Vol 6 (1) ◽  
pp. 8-12
Author(s):  
Vikaas Budhwaar ◽  
Yogesh Rohilla ◽  
Manjusha Choudhary ◽  
Prateek Kumar
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Marketing Authorization ◽  
Indian Agent ◽  
Registered Office ◽  
A Company ◽  
Do So

India is a huge market for medical devices and is increasing constantly for the last few years. The registration certificate and import license is mandatory for a manufacturer of India who wishes to import any medical device in India. If a company which wants to imports its medical devices in India does not have a registered office in India it needs Indian agent authorized by CDSCO, to do so. Duly filled form-10 is required to be submitted for import license, while form-44 duly filled is required to be submitted for marketing authorization of a new medical device or its re-registration. The review focuses on regulation concerned to the registration procedures import of a new medical device in India with latest amendments in the regulation concerned.

scholarly journals Medical device safety: Investigating contributions of human factors

2016 ◽  
Author(s):  
Kathrin Lange
Keyword(s):  
Adverse Events ◽  
Human Factors ◽  
Medical Device ◽  
Medical Devices ◽  
Human Error ◽  
Long Term Memory ◽  
Serious Adverse Events ◽  
True Value ◽  
Federal Institute ◽  
Medical Device Safety

The core tasks of the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte [BfArM]) with respect to medical device safety include evaluating risks arising from the use or application of medical devices (based on incident reports), assessing and coordinating the counter-measures to be taken (i.e. corrective actions), and authorizing clinical trials of medical devices and evaluating the corresponding serious adverse events. Additionally, the BfArM also conducts research on medical device safety, specifically on the possibilities and challenges of data-driven approaches to detect and evaluate risk and on the contribution of human factors to device safety – i.e. factors that may have an impact on how users interact with a device. The present talk focuses on this latter issue. The significance of addressing human factors relating to the use of medical devices results from the contribution of human error to adverse events. For instance, an involvement of human error could be identified in a good 10% of the reports of suspected device-related incidents evaluated by the BfArM between 2005 and 2014. For several reasons, it may be assumed that the true value of device-related incidents involving human error is even larger and that the potential for human error is likely to increase in the future. To effectively reduce the risk for human error – or block its negative outcome - it is imperative to not only identify human error as a significant cause of adverse events, but rather understand the causation of the error, including the conditions under which errors are likely to occur. This requires the analysis of the perceptual, cognitive (e.g. attention, working memory, long term memory), motor or motivational processes involved and the identification of relevant factors at the various levels of the socio-technical system. In our research, we currently pursue two selected human factors issues, selected based on the incident-data collected at the BfArM and on the current literature: Insufficient device knowledge and the multi-faceted issue of device alarms, the latter including both the users’ interactions with alarming devices and their perceptual, cognitive, or motor responses to the devices’ alarms.

scholarly journals Status Analysis on the Marketing Authorization Holder of China's Drugs

2020 ◽  
Vol 185 ◽  
pp. 04009
Author(s):  
Yu Haishi ◽  
Jiang Yingzhu ◽  
Zhou Weijun
Keyword(s):  
Dosage Form ◽  
Product Category ◽  
Dosage Forms ◽  
Marketing Authorization ◽  
Geographical Differences ◽  
Marketing Authorization Holder ◽  
Full Implementation ◽  
Approval Time ◽  
Authorization Holder ◽  
Status Analysis

We analyze the basic situation of Marketing Authorization Holder (MAH) of drugs in China. Mathematical analysis was carried out on the approval time, product category, dosage form, listing permit holder and production unit of 3239 MAH of drugs in China as of July 31, 2019. We found the following results. The approval time for MAH of drugs was concentrated in 2015, mainly based on chemicals, and the dosage forms were mostly tablets and injections. Furthermore, the number of MAH of drugs varies greatly among different provinces, and the number of Hebei, Guangdong, and Jiangsu ranks in the top three. Thirdly, there are time differences, variety types and geographical differences in the MAH of drugs. This is the application for examination and approval after the full implementation of the MAH of drugs system, and the patent and intellectual property protection in the process of entrusted production technology transfer. The research provides reference for enterprise declaration and regulatory approval management after the full implementation of the MAH system in China.

scholarly journals Marketing Analysis: Antiemetic Drugs on the Pharmaceutical Market of Uzbekistan

2021 ◽  
Author(s):  
Samedinova Dilnoza Nuriddin qizi ◽  
Yunusova Kholida Mannanovna
Keyword(s):  
Medical Practice ◽  
Medical Devices ◽  
Medical Equipment ◽  
Dosage Forms ◽  
Pharmaceutical Market ◽  
State Register ◽  
Antiemetic Drugs ◽  
Marketing Analysis ◽  
The Republic ◽  
Audit Program

Abstract In this study, we analysed, with the help of the “State Register of Medicines, Medical Devices and Medical Equipment Permitted for Use in Medical Practice of the Republic of Uzbekistan”, the number, dosage forms and cost of registered antiemetic drugs in 2016-2020 based on the DRUG AUDIT program, which offers a database of information from 2016 to 2020.

Sign in / Sign up

Export Citation Format

Share Document