NEW product development laws, DRUG laws, MEDICAL communication
Abstract
The article reports that the European Union and Canada have agreed to exchange confidential information about the authorization and safety of medicines. The agreement was signed between the European Commission, the European Medicines Agency (EMEA), and the Health Products and Food Branch of Health Canada. The deal is expected to accelerate access to innovative drugs and improve performance and safety of drugs. Examples of information that can be exchanged are position papers on future legislation and scientific advice on product development.
DRUG side effects, MEDICATION therapy management, IRELAND. Medicines Board, HERBAL medicine, GOVERNMENT policy
Abstract
This section offers news briefs related to pharmaceutical medicine as of April 2014. The European Medicines Agency (EMA) is planning to publish full clinical trial data submitted by companies starting January 1, 2014. Adverse drug reaction (ADR) reporting guidance was included by Accreditation Canada in its latest Medication Management Standards. A decision was made by the Irish Medicines Board (IMB) to regulate Ireland's herbal medicines market.
The article reports on the new agreement between Canada and the European Union which will allow their respective regulatory experts to share confidential information, such as safety and authorization issues regarding medicines on the market or in development. According to the report, the European Commission (EC) and the European Medicines Agency (EMEA) struck the deal with the Health Products and Food Branch of Health Canada at their bilateral meeting on December 7, 2007 in Brussels, Belgium.
Published
2008
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