has announced that the European Union's Committee for Proprietary Medicinal Products
(CPMP), the scientific committee of the European Medicines Evaluation Agency (EMEA), has recommended granting Marketing Authorisation for Hepsera(TM) (adefovir dipivoxil) for the treatment of chronic hepatitis B in all 15 member states of the European Union.
"It won't be so easy to implement this in the current system", according to Daniel Brasseur, the Chairman of the Committee for Proprietary Medicinal Products
at the European Agency for the Evaluation of Medicinal Products, who admits the new clinical trials rules are not working efficiently.
The European Union's principal advisory body on medicines, the Committee for Proprietary Medicinal Products
(CPMP), has come up with guidance on what can be done to counter biological warfare attacks.
Amgen (Nasdaq:AMGN) has announced that the European Union Committee for Proprietary Medicinal Products
(CPMP) has recommended granting Kineret(R) (anakinra) a marketing authorisation for the treatment of the signs and symptoms of rheumatoid arthritis (RA) in combination with methotrexate, in patients with an inadequate response to methotrexate alone.
And a new clause would allow EU authorisation of generic products submitted on the basis of data relating to already-authorised products, subject to certain conditions (where the summary of the product characteristics is in all respects consistent with that of the medicinal product authorised by the EU, and, the generic medicinal product is authorised under the same name in all the Member States where the application has been made.)The Committee for Proprietary Medicinal Products
would become the Committee for Human Medicinal Products, with a brief widened so that at the request of the Executive Director of the Agency or the Commission representative, it shall draw up any opinions on scientific matters concerning medicinal products for human use.
Some members of the Committee for Proprietary Medicinal Products
(CPMP) raised questions, for which additional data will be available in the near future.
The EU's principal scientific committee on human medicines, the Committee for Proprietary Medicinal Products
, held its first full meeting in late January in its new form.
But the European Federation of Pharmaceutical Industries and Associations says this is too soon - particularly if the opinion on an application is negative.Under the EU's authorisation system, the Committee for Proprietary Medicinal Products
gives an opinion which is then submitted to the European Commission for approval.