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Transparency Directive (COM (2012)0084) - (29 May 2012)
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...
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GMP for Excipients (June 2012)
Directive 2011/62/EU (‘’Falsified Medicines Directive’’) of 08 June2011 amending Directive 2001/83/EC describes requirements for excipients. e.g.Article 46f requires the holder of the manufacturing...
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API Supply Chain Oversight and QP role (June 2012)
A number of new regulations are in the process of being developed or implemented. These include :-Chapter 5 – API oversight / traceabilityFalsified Medicines Directive – importation of API’sAnnex 16...
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Audit of suppliers (June 2012)
There are increasing challenges to the Quality management of pharmaceutical supply chains, for example:Increasing complexity of the pharmaceutical supply chainIncreasing number of suppliers (many of...
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GMP for APIs (June 2012)
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. This may lead to EU-specific...
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Falsified Medicines Directive (FMD) Provisions Relating to Importation of...
Article 1 of the Falsified Medicines Directive (FMD) requires all manufacturing authorisation holders to ensure that APIs meet the requirements of GMP. Member states likewise have a duty to ensure that...
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Internet Sales and Access to Safe Medicines
As more and more patients look to the Internet for the supply of medicines, IFPMA, PhRMA, EFPIA, and JPMA are united in the effort to protect their safety. We are committed to promoting access to...
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EFPIA Position Clinical trial standards in developing and emerging countries...
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. While in the past the majority...
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EFPIA Position on the Legal Proposal for a Regulation of the European...
EFPIA welcomes the Commission’s proposal for revised clinical trial legislation in the interest of maintaining the EU’s competitiveness in clinical research. EFPIA acknowledges that the Commission...
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EFPIA Position on Transparency of information on Clinical Trials included in...
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. Therefore the...
View ArticleDisappointing decision by the Indian Supreme Court to deny a first patent to...
This week the Indian Supreme Court denied the patent application of Novartis for its breakthrough medicines Glivec even though it was rewarded a patent in 40 other countries including China, Russia and...
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