The Challenges of the New EU Pharmaceutical Legislation
In the domain of public policy on pharmaceuticals, protecting public health requires a dual strategy: robust regulation on the one hand and stimulation of competitiveness and innovation on the other. Regulation must be robust to ensure that only medicines meeting exact standards of safety, quality and efficacy are authorised for human and animal use. At the same time, competitiveness and innovation must be stimulated. Without innovation in pharmaceuticals, the incurable diseases of today will remain incurable. Competitiveness drives innovation and innovation saves lives. Increased competitiveness of the pharmaceutical sector will not only better protect public health, but will also create high quality jobs and create growth. In this context the implementation of the G10 recommendations, particularly regarding the pricing and reimbursement of medicines by Member States, remains a considerable challenge. In order to make potentially life-saving pharmaceuticals available as soon as possible to patients and to enable industry to quickly recoup its investments and to reinvest into future R&D, still existing delays in some Member States between marketing authorization and the selling of the medicine have to be minimized. The proposed paediatric regulation, currently under discussion in Council and Parliament, is another example where a better protection of (childrens) health goes together with a stimulation of competitiveness and innovation in the European pharmaceutical industry. This publication focuses on the recent review of the EU pharmaceutical legislation. The revised legislation is a key part of the above-mentioned dual strategy.
What people are saying - Write a review
We haven't found any reviews in the usual places.
active substance adopted ANDA approval Article authorisation procedures blood candidate countries centralised procedure clinical trials Committee Community code relating concerning Council of Europe diseases Drug Application drug information EMEA ensure established EudraVigilance Europe European Agency European Commission European legislation European Medicines Agency European Medicines Database European medicines system European Parliament European pharmaceutical European Pharmacopoeia European Union framework free movement harmonisation health protection herbal medicinal products human and veterinary implementation improve innovation IOS Press manufacturers market exclusivity marketing authorisation measures Member mutual recognition procedure non-prescription medicines organisation Orphan Drug patent infringement pharmaceutical industry Pharmaceutical Law pharmaceutical legislation pharmaceutical sector Pharmaceuticals Policy pharmacovigilance products for human proposal proprietary medicinal products public health quality and safety Regulation EC regulatory requirements Romania scientific self-medication strategy Study of Pharmaceutical telematics therapeutic tissues and cells traditional herbal medicines Treaty Treaty of Amsterdam Waxman-Hatch Act