_ Thrusday 05 August 2004


10% INCREASE OF FRENCH MA FEES

AFSSAPS,French regulatory agency has increased of 10% the fees for Marketing Authorization (MA) evaluation. It leads to the following charges for pharmaceutical companies :
Product with new active substance : 25 400 Euros
Product with new dosage : 12 700 Euros
Product for new indication : 16 790 Euros
Generic drug : 10 110 Euros
New fee for applications to parallel import a medecine:10 110 Euros ,for a five-yearly renewal : 674 Euros and to have a reimbursed product : 2875 Euros


_ Thrusday 05 August 2004


EU PAEDIATRIC REGULATION POSTPONED

The draft Regulation for the EU legislation on paediatric testing of medicines was not adopted this month as expected by the EU commission and so will be delayed.
The Regulation aim is to define the framework of conducting clinical trials in children and to give incentives to companies involved in such trials by as an example extending the patent validity period as it is done by the US legislation.
There is no fundamental question but the directorate is still preparing the final parts of the draft which shall be presented after vacation to the EU commission for adoption before EU legislation process continuation.


_ Thrusday 05 August 2004


2003 REIMBURSED DRUGS SALES IN FRANCE

In 2003,the growth of reimbursed drugs sales reached 6% instead of 4.6% in 2002.
Among 337 therapeutics classes,23 represent almost 50% of all sales and 11 classes 33% (DREES statistics).
10 therapeutic classes constitute the most part of the sales increase (77%),the classes (coronary therapy,antibiotics,anti-ulcers ) with the lowest growth correspond to those where generic products are commercialized.
If the generic market is in a large expansion,38% in 2003 instead of 22% in 2002 ,it remains a small part (5.4%)of the pharmaceutical market


_ Thrusday 01 June 2004


UK : OTC STATIN

UK Committee on safety medicines has given to the simvastatin 10mg tablets OTC status. A customer, after information given to the pharmacist about his cholesterol status, will be able to buy this drug without physician prescription .The purpose is to protect as much as possible greatest part of the patients from coronary heart disease risk, cause of 110 000 deaths in UK by year. This decision supported by the pharmacists and by the British Heart Fundation has not received the support of the Consumers’Association and the British Medical Association which claim that this decision will have a negative more than positive effect for the patients. Simvastatin will be on the market as OTC in next summer.


_ Thrusday 01 June 2004


EU : EMEA COMMENTS ABOUT CLINICAL DATA

The European Medicines Agency (EMEA) attract attention of pharmaceutical companies requesting an EU MA registration on the importance of the quality of the clinical data file . To have the best registration chance of success, EMEA recommends to have the CPMP advise and if necessary a profitable exchange with this Committee. Indeed 25-30% MA registrations are rejected due to the clinical data issues. The main reasons of these rejects due to the clinical development programm are : choice of endpoints,justification of dose regimen and poor clinical efficacy. The biotech new product with their innovative nature will lead to rejects increase.


_ Thrusday 01 June 2004


A CJCE DECISION WHICH COULD BENEFIT TO GENERICS

In its judgment of the 29th April, the European Communities Justice Court has judged that “during the examination of two MA hybrids registration requests of products B and C referring to a product A, the Competence Authority of a member state doesn’t infringe the general non discrimination principle because it demands only a complete clinical data related to the biodisponibility for the product B for the MA delivery but not after review of the these B data, the same complete data for the Product C. This decision has been taken in the frame of the Novartis pharmaceutical dispute after the MA delivery by the Medecines Control Agency for an abridged hybrid procedure for the immunosuppressor Sancya (cyclosporin) from Sangstat UK .This decision could open the way to the realization of data cross paths when regulatories authorities deal with generic versions MA registration request of revised formulations of reference products.