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Rosiglitazone: a question mark about the safety
The European Medicines Agency (EMA) is reassessing the hypoglycemic medicines containing rosiglitazone used in the treatment of type 2 diabetes, following the publication of new studies on the cardiovascular risk associated with their use. The Committee for Medicinal Products for Human Use (CHMP) of the EMA, at its next plenary meeting (19-22 July 2010), will decide whether it is appropriate to withdraw, suspend or modify the marketing authorisation of these medicines.
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Recommendations of the European Medicines Agency (EMA) regarding radiopharmaceuticals
In response to the shortage of Technetium-99m (Tc-99m) on the European market, the EMA organized on February 4-5th 2010 the workshop "Current use and future needs of radiopharmaceuticals labelled with radionuclides produced in reactors and possible alternatives". The workshop primarily addressed the current use and future role of radionuclides that are produced in reactors (in particular Tc-99m) and which are being used for diagnostic or therapeutic purposes in nuclear medicine.
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Ethanol-containing medicines: precautions and recommendations
The Commission for Medicinal Products for Human Use, the Commission for homeopathic medicines and the Commission for Herbal Medicinal Products issued recommendations on medicines - in particular medicines for children - containing ethanol (alcohol) as an excipient. The FAMHP approves these recommendations aimed to protect patients and especially children. Applicants / marketing authorisation/registration holders of such medicines are invited to take account of these recommendations.
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Clinical Trials: Circular 567
The Federal Agency for Medicines and Health Products (FAMHP) wishes to inform sponsors of clinical trials and experimental drug manufacturers, hospital pharmacists, hospital head doctors, hospital directors about the publication of a new circular on the activities of producing experimental medicines.
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Nuclear Medicine: shortage of Technetium-99m (Tc-99m)
Tc-99m is a radioisotope used in nuclear medicine for diagnosing many diseases. The majority of reactors producing mainly Mo-99 parent-isotope of Tc-99m, have been shut down for maintenance or due to technical problems. The two reactors that are still active are fully utilized. However, the amount of Tc-99m is not currently sufficient to meet all needs. Priorities have been defined.
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Reporting by patients suffering from side effects related to the use of medicines
Since the founding in 1976 of its Belgian Centre for Pharmacovigilance (CBPH), the Federal Agency for Medicines and Health Products (FAMHP), which is the competent authority regarding medicines, received more than 50,000 notifications, mainly serious adverse effects, from health care providers and the pharmaceutical industry (legal requirement since 1995). On its own initiative, Test-Achats created in 2006 a contact point for patients to report adverse reactions and other problems concerning medicines. In 2007 the FAMHP and Test-Achats concluded a collaboration agreement for the exchange of information on adverse events reported by the patients.
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Launch of "VIG-NEWS"
The Federal Agency for Medicines and Health Products (FAMHP) announces the availability of its electronic newsletter "VIG-NEWS" for the attention of health professionals. The VIG-NEWS is a selection of recent news of pharmacovigilance from different sources.
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Communication from the FAMHP and the FPS Public Health concerning "electronic cigarettes"
The Federal Agency for Medicines and Health Products (FAMHP) and the Federal Public Service Health, Food Chain Safety and Environment (FPS Health) have noticed that more and more so-called « electronic » cigarettes, cigars and pipes are available on the market. The FAMHP and the FPS Health wish to, once again, warn people about the potential danger of this type of electronic device and the problems they can cause.
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e-Submission guideline: new version (2.9)
The EU's Better Regulation policy aims notably at simplifying and improving existing regulation. In this context, the “e-submission guidelines" concerning the electronic submission of dossiers for variation of marketing authorization of medicines for human use has been updated. The date of implementation of this new version has been set at 01.06.2010.
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Sunset clause: updated information
The FAMHP would like to bring to the attention of the Marketing Authorisation (MA) or registration holders of medicines the publication of a new version of the document concerning the application of measures relating to the sunset clause in Belgium for medicinal products authorised at the national level. This document outlines the basic rules of the sunset clause and provides all the information on exemptions.
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