Key Industry Websites
SGS has identified some key industry websites that each provides important information about scientific and regulatory clinical research developments.
Global Clinical Research Organizations
- The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- ICH “brings together the regulatory authorities of Europe, Japan and the United States … to discuss scientific and technical aspects of product registration”. Among other things, ICH sets standard guidelines for conducting clinical trials.
- ICH “brings together the regulatory authorities of Europe, Japan and the United States … to discuss scientific and technical aspects of product registration”. Among other things, ICH sets standard guidelines for conducting clinical trials.
- Clinical Data Interchange Standards Consortium (CDISC)
- CDISC is a global, nonprofit organization working to provide data standards which are “vendor neutral and platform independent” to improve the portability and efficiency of medical research data, including data obtained from clinical trials.
- Food & Drug Administration (FDA)
- The FDA is the Health Authority of the United States and, in part, is responsible for regulating the clinical development and marketing approval of medical devices and medicinal products.
- The FDA is the Health Authority of the United States and, in part, is responsible for regulating the clinical development and marketing approval of medical devices and medicinal products.
- European Medicines Agency (EMEA)
- The EMEA acts as the Health Authority for European Union Member states, evaluating and providing guidance to member states on human and veterinary medicines. Under the “Centralized Procedure” of submitting marketing authorizations, EMEA is responsible for granting EU wide authorization.
- The EMEA acts as the Health Authority for European Union Member states, evaluating and providing guidance to member states on human and veterinary medicines. Under the “Centralized Procedure” of submitting marketing authorizations, EMEA is responsible for granting EU wide authorization.
- Heads of Medicines Agencies (HMA) Directory
- The HMA Directory consolidates links to many of the Europe’s individual country Health Authority’s websites in one central location.
- The HMA Directory consolidates links to many of the Europe’s individual country Health Authority’s websites in one central location.
- Health Canada
- Health Canada is the Health Authority for Canada, evaluating and providing marketing approval for pharmaceuticals, medical devices, and biologics.
- Health Canada is the Health Authority for Canada, evaluating and providing marketing approval for pharmaceuticals, medical devices, and biologics.
- French Health Products Safety Agency (AFSSAPS)
- AFSSAPS is the Health Authority of France regulating clinical trials and marketing authorization for, but not limited to: medicinal products, gene and cell therapy products, and medical devices.
- AFSSAPS is the Health Authority of France regulating clinical trials and marketing authorization for, but not limited to: medicinal products, gene and cell therapy products, and medical devices.
- Medicines and Healthcare products Regulatory Agency (MHRA)
- MHRA is the Healthy Authority of the UK regulating marketing authorization for, but not limited to: medicinal products, gene and cell therapy products, and medical devices.
- Drug Information Association (DIA)
- DIA is an professional industry organization which provides information exchange forums, education and training for those involved in: “the discovery, development, regulation, surveillance, or marketing of pharmaceuticals or related products”
- DIA is an professional industry organization which provides information exchange forums, education and training for those involved in: “the discovery, development, regulation, surveillance, or marketing of pharmaceuticals or related products”
- European Federation of Pharmaceutical Industries and Associations (EFPIA)
- EFPIA is an organization comprised of pharmaceutical industry organizations and pharmaceutical companies of Europe.
- EFPIA is an organization comprised of pharmaceutical industry organizations and pharmaceutical companies of Europe.
- The Pharmaceutical Research and Manufacturers of America (PhRMA)
- PhRMA is an organization comprised of pharmaceutical research and biotechnology companies of the United States.
- PhRMA is an organization comprised of pharmaceutical research and biotechnology companies of the United States.
- International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
- IFPMA is an organization comprised of pharmaceutical and vaccine companies representing both developed and developing countries.
- IFPMA is an organization comprised of pharmaceutical and vaccine companies representing both developed and developing countries.
