Spain’s new three-pronged strategic plan to bolster the pharmaceutical industry will also strengthen research and innovation, improve timely access to medicines and ensure strategic autonomy in the production of medicines.
Spain Bets On New Pharmaceutical Strategy To Boost Access And Innovation
The strategy includes a committee made up of pharmaceutical industry representatives and ministers to discuss the impact of regulatory proposals.
More from Spain
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The first reimbursement reports published by the Spanish health ministry to improve transparency focus on CSL’s Hemgenix, BMS’ Camzyos and Pfizer’s Velsipity.
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CSL Behring explains how it worked with authorities in Denmark, Austria, England, Scotland, Spain and Switzerland to secure innovative access arrangements suitable to each nation’s “unique needs” for its one-time gene therapy, Hemgenix.
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The strategy includes a committee made up of pharmaceutical industry representatives and ministers to discuss the impact of regulatory proposals.
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A draft royal decree would pave the way for more transparency in pricing and reimbursement decision-making processes and boost competition to increase the participation of generic medicines.
More from Legislation
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The Clinical Trials Regulation was “supposed to harmonize” requirements in the EU, but instead it is giving some countries the chance to get ahead by offering faster approval timelines, notes Telethon’s head of regulatory affairs.
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Industry likely wants Grace Graham to take the FDA’s top policy and legislative role, but she may be passed over for someone more tied to HHS Secretary Robert F. Kennedy Jr.’s interests.
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Trial sponsors in Germany should start preparing negotiation strategies to tackle difficult discussions with trial sites over standardized clauses.