Comparative approaches to pharmaceutical price regulation in the European Union.
(49/804)
AIM: To review pharmaceutical price regulation methods in countries of the European Union (EU), in terms of the anticipated impact of regulation on pharmaceutical expenditures and evidence of actual outcomes. METHOD: An extensive search was performed of medical and economic studies on regulatory interventions specifically targeting pharmaceutical prices in EU countries, published between January 1990 and April 2002. Both peer-reviewed and "gray" literature were systematically reviewed. RESULTS: Four principle approaches to pharmaceutical price regulation with some methodological differences were identified in EU countries, as follows: fixed pricing, cost-effectiveness pricing, profit controls, and reference pricing. Actual evidence of the impact of price regulation was limited in many of these countries. Cross-country comparisons suggested that limiting the rise of pharmaceutical prices did not equate to controlling the rise of pharmaceutical expenditures because of the volume effect of utilization. CONCLUSIONS: Supply-side regulation without the simultaneous use of demand-side incentives and volume controls does little to control the rise in pharmaceutical expenditures. The types of needed demand-side controls depend on the context of the individual country, on political priorities, and on the type of supply-side regulation in place. (+info)
Specialist training in rheumatology in Europe.
(50/804)
Rheumatology is a broad discipline managing a spectrum of different conditions and there are divergences in what is routinely treated by rheumatologists both within and between countries. The free movement of doctors throughout the European Community has lead to moves to harmonize specialist training to ensure common standards of care. The Union Europeene des Medecins Specialistes (UEMS) has developed recommendations for the specialist training of rheumatologists in Europe that recognizes the broad definition of the discipline and the diversity of clinical practice in Europe. The core curriculum aims to provide a common standard around which to develop locally applicable national curricula. The provision of high quality care requires some assessment of training and competency as well as continuing professional development and ways of ensuring the provision of this throughout the European Community to a mutually high standard are being developed. The future may see more overlap in the training of all the disciplines concerned with the management of those with musculoskeletal conditions to their benefit. (+info)
To keep the catch - that is the question: a personal account of the 3rd Annual EULAR Congress, Stockholm.
(51/804)
The 3rd Annual EULAR Congress, held in Stockholm on 12-15 June 2002, had a turnout of 8300 delegates, almost identical to last year's record attendance level in Prague. The venue was close to ideal, allowing ample space for poster sessions in the exhibition hall. The manned poster sessions were well attended, even on the last day of the Congress. The numerous invited speakers represented the world's elite, allowing the staging of excellent state-of-the-art podium sessions. The aim of attracting the young scientific community was partly achieved, but individual delegates' dependence on industry sponsorship poses potential problems. The organization was a big improvement compared to that of the two previous congresses. Approximately 1800 abstracts were submitted, an increase of 50%, resulting in a higher quality of accepted abstracts. The satellite symposia held every morning and late afternoon were well attended; thus, industry exposure of new products, both in podium sessions and at the exhibitions, was well accommodated. The Annual EULAR Congress consolidates its position as one of the two most important annual congresses of rheumatology, but EULAR economy and commercial aspects are still too dominant in relation to science. (+info)
International Conference on Harmonisation; choice of control group and related issues in clinical trials; availability. Notice.
(52/804)
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "E10 Choice of Control Group and Related Issues in Clinical Trials." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance sets forth general principles that are relevant to all controlled trials and are especially pertinent to the major clinical trials intended to demonstrate drug (including biological drug) efficacy. The guidance describes the principal types of control groups and discusses their appropriateness in particular situations. The guidance is intended to assist sponsors and investigators in the choice of control groups for clinical trials. (+info)
International Conference on Harmonisation; guidance on S7A safety pharmacology studies for human pharmaceuticals; availability. Notice.
(53/804)
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "S7A Safety Pharmacology Studies for Human Pharmaceuticals." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides a definition, general principles, and recommendations for the nonclinical safety pharmacology studies. The guidance is intended to help protect clinical trial participants and patients receiving marketed products from potential adverse effects of pharmaceuticals, while avoiding unnecessary use of animals and other resources. (+info)
International Conference on Harmonisation; guidance on M4 common technical document; availability. Notice.
(54/804)
The Food and Drug Administration (FDA) is announcing the availability of guidance entitled "M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use" (M4CTD). The guidance was developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance, which is being made available simultaneously in four parts (general organization, quality, safety, and efficacy), describes a harmonized format for new product applications (including applications for biotechnology-derived products) for submission to the regulatory authorities in the three ICH regions. The M4 CTD is intended to reduce the time and resources used to compile applications, ease the preparation of electronic submissions, facilitate regulatory reviews and communication with the applicant, and simplify the exchange of regulatory information among regulatory authorities. (+info)
International Conference on Harmonisation; guidance on Q1A stability testing of new drug substances and products; availability. Notice.
(55/804)
The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled "Q1A(R) Stability Testing of New Drug Substances and Products." The revised guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance sets forth recommendations on the information to be submitted in the stability data package for a new drug substance or drug product for a registration application within the three regions of the European Union (EU), Japan, and the United States. The purpose of there vision is to add information to certain sections and to provide clarification to other sections of the guidance. (+info)
International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); final guidance for industry on "studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing" (VICH GL23); availability. Notice.
(56/804)
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry (116) entitled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food:Genotoxicity Testing" (VICH GL23). This final guidance has been adapted for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products(VICH) from a guidance regarding pharmaceuticals for human use, which was adopted by the International Conference on Harmonisation of Technical Requirements for Approval of Pharmaceuticals for Human Use (ICH). This final VICH guidance document recommends a basic battery of tests that can be used to evaluate the genotoxicity of veterinary drug residues in human food in the European Union, Japan, and the United States (+info)