News in brief

Medicinal products for human use cannot be awarded supplementary protection certificates in an EU member country when they were granted a veterinary market authorisation in another EU country before June 1992, the European Court of Justice has ruled. That date was when EU regulation 1768/92 on supplementary protection certificates for medicinal products came into force.

International trade controls have been imposed on some plants and trees with medicinal properties, to guarantee their future abundance for the pharmaceutical industry. A conference of parties to the Convention on International Trade in Endangered Species (CITES) in Bangkok strengthened rules on trading in medicinal plants, including hoodia, used in diet pills; cistanche, a natural tonic; and the Chinese yew tree, which boasts anticancer properties.

The European Medicines Agency (EMEA) and the US FDA will stage a pilot of their new confidentiality agreement aimed at enabling pharmaceutical companies to obtain parallel advice from the two bodies. The deal involves exchanging information, including on pre-authorisation and post-authorisation applications, inspections and guidance documents, see Link 1

An advocate general of the European Court of Justice has advised that pharma companies may use fast-track procedures to gain market approvals for medicines with the same active ingredient as established drugs, but using different salts. Francis Jacobs said EU directive 65/65/EEC allowed this, so long as the medicines 'do not differ significantly as regards safety or efficacy'.