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GlaxoSmithKline (GSK) drug Wellbutrin XR has received a marketing license in the Netherlands, making it the first antidepressant of its kind to be approved in Europe, the company announced.
Following months of debate, the European Parliament (EP) Dec. 13 voted 529-98 (with 24 abstentions) to adopt the compromise chemicals regulations it negotiated with the European Council of Ministers.
In a slight concession to the medical device industry, the European Parliament recently agreed to delay a proposed ban on mercury-containing sphygmomanometers (blood pressure monitors) while the European Commission conducts a review into safer and reliable alternatives.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published a consultation paper seeking comment on a proposed hike in industry fees for medical device regulatory activities.
The manufacturing, release, labeling and import into Germany of investigational medicinal products (IMPs) are regulated by the country's 1985 Regulations for Pharmaceutical Entrepreneurs.
In a slight concession to the medical device industry, the European Parliament Nov. 14 agreed to delay a proposed ban on mercury-containing sphygmomanometers (blood pressure monitors) while the European Commission conducts a review into safer and reliable alternatives. Read More
With the European Commission (EC) slated to address a series of revisions to its medical device directive next month, manufacturers should prepare for “some significant changes” in the way the European Union (EU) regulates medical software, clinical investigations, data banks and other aspects of the industry.
Nanotechnology should be approached in a spirit of international collaboration and, as a part of this global picture, industry must be part of the solution in regulating nanotechnology, said Philippe Martin, directorate-general of the European Commission’s (EC) Health and Consumer Protection branch and a principal administrator for the EC’s nanotechnology policy and development efforts.
Recognizing that the spread of counterfeit drugs is not confined to developing, poorly regulated countries, the European Parliament (EP) Sept. 9 approved a joint resolution calling on the European Union (EU) to play an aggressive role in the global fight against illegal medicines.