| 1. |
- Hedenmalm, Karin, et al.
(författare)
-
A Swedish Regulatory Perspective on European Risk Management
- 2007
-
Ingår i: International Journal of Pharmaceutical Medicine. - 1364-9027 .- 1473-5679. ; 21:2, s. 131-145
-
Tidskriftsartikel (refereegranskat)abstract
- Worldwide, drug regulation safety requirements in the past can be seen as responses to major drug disasters, such as thalidomide or diethylstilbestrol. In the light of the more recent drug disasters, the public is less willing to accept risk associated with drug therapy. Increased emphasis has to be placed on the proactive identification of potential safety issues with new drugs at the earliest possible occasion, and before large populations have already been exposed to the drug. The concept of balance between potential benefit and risk also has to be communicated more strongly.This article presents an overview of spontaneous reporting systems and signal detection and evaluation. It also discusses regulatory issues and risk management with an emphasis on the new European Community system. A number of new initiatives and obligations are introduced that are handled by the European regulatory agencies.
|
|
| 3. |
- Reihart, D, et al.
(författare)
-
Clinical Trials in Russia: Growing Experience and Revision of Regulations.
- 2005
-
Ingår i: International Journal of Pharmaceutical Medicine. - 1364-9027. ; 19:2, s. 73-76
-
Tidskriftsartikel (refereegranskat)abstract
- Clinical trials of pharmaceuticals have been running in Russia for more than ten years and while it is an attractive location for research, it remains a largely untapped resource as researchers look to expand patient recruitment outside the Western world. While academic sites like Moscow, St Petersburg and Novosibirsk have all gained experience in clinical trials, smaller hospitals in peripheral sites have also participated. During 2004, more than 40 000 patients were recruited and more than 500 clinical trials were initiated in Russia. Nine of 14 US Food and Drug Administration inspections performed in the country since 1994 went without findings and no inspection required official follow-up action from the agency, indicating that high-quality data can be obtained from Russia. While the recruitment and quality in clinical trials meet very high standards in Eastern European countries, the lack of information on local rules and regulations is still a factor which limits this under-used region. Executive power reforms launched in Russia in 2004 have affected clinical trial performance and brought the legislation into accord with international guidelines. State regulation and supervision of clinical trials is under the jurisdiction of the Federal Service for Control in Healthcare and Social Development, which itself is a part of the Ministry of Health. Two levels of ethical review are present in Russia, the National Ethics Committee (NEC) and the local ethics committees that exist at the majority of investigative sites. Approval at all levels is required before launching a clinical trial. Among other developments, revised regulations have introduced a 30-day period within which the NEC has to give its opinion on a trial, putting a limit to the time allowed for clinical trial approval. Recent changes in legislation have made the process of clinical trial approval better defined and more transparent, thus, contributing to a decrease in the administrative burden. Economic development in Russia, while not fast enough, has lead to improvements in living standards and has helped eliminate some of the ethical concerns. We now await the future to see to what degree the potential of Russia to undertake clinical trials is realised.
|
|
