- BARQA
British Association of Research Quality Assurance. The primary purpose of BARQA is to assist members in understanding, interpretation and implementation of national and international regulations covering GLP, GCP and GMP. - CBG
This is the website of the Dutch Medicines Evaluation Agency (Agentschap College ter Beoordeling van Geneesmiddelen). It provides information on the following: - Summary of product characteristics of licenced medicines;
- The procedure for reporting adverse drug reactions by licence holders of products that are registered in the Netherlands;
- The procedure for reporting adverse drug reactions of non-registered medicinal products by licence holders;
- An overview of reports that must be made by the licence holder within 15 days.
- CCMO
The Central Committee on Research Involving Human Subjects (Dutch abbreviation: CCMO). It is the responsibility of this committee to recognise Ethics Committees in the Netherlands and review protocols in certain cases. Guidelines, News and FAQs concerning the implementation of the Medical Research for Human Subjects Act can be found there. - DIA
The Drug Information Association (DIA) is a non-profit scientific association with a membership of over 15,000. These members are primarily from the international pharmaceutical industry, regulatory agencies and academia. - EMEA
The European Agency for the Evaluation of Medicinal Products (EMEA) was established by the European Council. The new European registration system is a step towards the establishment of a unified market for medicinal products. It intends to promote the free circulation of pharmaceuticals within the EU while reinforcing the protection of public health. - FDA
The U.S. Federal Drug Administration. An excellent website with information on all the areas of activity and listings of all standard FDA forms, including possibilities for downloading. - ICH
This is the website of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
ICH is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. - Stichting Nefarma
The website of the Dutch Association for research based pharmaceutical industries. - TOPRA
TOPRA is the global organisation for Regulatory Affairs professionals and for those who have an interest in Regulatory Affairs in the healthcare sector. Websites of Agencies and Health Ministries have been listed on this site. - VWS
The website of the ministry of Health, Welfare and Sport, that contains all regulatory information on medicines (policy).
