The EMA report dates until June 30, 2011, at which time 627 Traditional Herbal Medicinal Products Directive (THMPD) registrations had been granted across the European Union, with 268 added over the 6-month period of time.
Although this is a significant number for the first six months of 2011, compared to 225 registrations for the whole of 2010, the ANH played down the level of activity.
Trend towards saturation?
“The rate at which new traditional use registrations (TURs) are being granted has dropped through the floor,” said the Alliance for Natural Health (ANH)
“Notable is a dramatic slowing in the relative rate of successful new registrations between 2010 and 2011, as compared with the previous two years. The question is: Does this reflect a trend towards saturation, or can we expect further surges of registrations in subsequent years?”
“Unfortunately, we suspect the former, unless something changes to make it substantially easier for smaller companies to gain TURs for their products, one of the key targets of our proposed legal challenge.”
The ANH has said it will challenge the regulation in the courts.
The UK, Germany, Poland, France and Austria are the countries with the highest TUR activity.
“TUR approvals have ground to a halt in Germany while accelerating considerably in Poland,” ANH observed.