e-Library : Position papers
Rss9 Apr 2013
This week the Indian Supreme Court denied the patent application of Novartis for its breakthrough medicines Glivec even thoug
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19 Nov 2012
Tags: Clinical trials, Position papers
EFPIA recognises that patients, researchers or the public are interested in knowing what new treatments are tested in clinical trials or what the results of these trials are.
30 Oct 2012
Clinical trials are an essential part of medical research. No new medicine can be approved without its safety and efficacy first being proven in several clinical trials.
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28 Sep 2012
EFPIA welcomes the Commission’s proposal for revised clinical trial legislation in the interest of maintaining the EU’s competitiveness in clinical research.
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24 Jul 2012
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12 Jun 2012
Tags: Access, Anti-Counterfeiting, Falsified medicines, Patients’ Access to Medicines, Regulation, Position papers
Article 1 of the Falsified Medicines Directive (FMD) requires all manufacturing authorisation holders to ensure that APIs meet the requirements of GMP.
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12 Jun 2012
Tags: Access, Anti-Counterfeiting, Falsified medicines, Patients’ Access to Medicines, Regulation, Position papers
Directive 2011/62/EU (“Falsified Medicines Directive”) of 08 June 2011 introduces a number of requirements aimed at strengthening the supply chain for medicinal products.
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12 Jun 2012
Tags: Access, Anti-Counterfeiting, Falsified medicines, Patients’ Access to Medicines, Regulation, Position papers
There are increasing challenges to the Quality management of pharmaceutical supply chains, for example:
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12 Jun 2012
Tags: Access, Anti-Counterfeiting, Falsified medicines, Patients’ Access to Medicines, Regulation, Position papers
A number of new regulations are in the process of being developed or implemented. These include :-
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12 Jun 2012
Tags: Access, Anti-Counterfeiting, Falsified medicines, Patients’ Access to Medicines, Regulation, Position papers
Directive 2011/62/EU (‘’Falsified Medicines Directive’’) of 08 June2011 amending Directive 2001/83/EC describes requirements for excipients. e.g.
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29 May 2012
Tags: Access, Development of Medicines, Healthcare systems, Patient, Patients’ Access to Medicines, Pricing, Reimbursement, Transparency, Value of the Industry, Position papers
The Commission proposal for a revised Transparency Directive (“the Proposal”) is an important and necessary step towards more efficient decision-making by member states in pricing and reimbursement (P&R) of medicines.