New EU Approach On Duplicate Marketing Authorizations Prompts Questions
The European Commission says there is no automatic link between the introduction of a duplicate marketing authorization by the holder of the original medicinal product (be it a chemical or a biological medicinal product) and the increased availability of a medicine.
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EU considers duplicate biologics
A European Commission consultation on ‘duplicate marketing authorisations for biological medicinal products’ has been welcomed by off-patent industry association Medicines for Europe. According to the consultation – which is open until 10 September 2018 – the Commission has “identified potential issues relating to the granting of duplicate marketing authorisations for biological medicinal products on the ground that they would be a ‘first generic’”. These issues “relate to the possible impact of such duplicate marketing authorisations on the biosimilar market, including potential anti-competitive effects”.
EU explains criteria for issuing duplicate marketing authorisations
Pharmaceutical companies seeking duplicate/multiple marketing authorisations for drugs approved under the European centralised procedure can now refer to a new document issued by the European Commission that explains the criteria applied for granting such authorisations1,2.
UK Aims To Quadruple Patient Recruitment To Industry Clinical Trials By 2027
The UK government has set aside dedicated funds to deliver ambitious changes that would make it quicker and easier for companies to trial more of their products in the National Health Service.