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New biosimilar pathways – key takeaways from the EMA’s draft reflection paper

European Pharmaceutical Review

4,5,6 However, these benefits are contingent on the ability to generate comprehensive, high-quality analytical and PK data packages. 10 The package, once adopted, is expected to introduce changes to regulatory exclusivity, market access, and competition rules for medicines, including biosimilars, across the EU. 2023;113:108-123.

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Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing

European Pharmaceutical Review

Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. International Council for Harmonisation (ICH), 2005. Q2(R2) Validation of Analytical Procedures: Text and Methodology.

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Regulating decentralised manufacturing in the UK – a legal perspective

European Pharmaceutical Review

In the EU, the EU pharmaceutical package of reform 5 includes a proposed new Directive, 6 which will replace the current Medicines Directive (2001/83/EC). Under the Blood Safety and Quality Regulations 2005. Provided certain requirements are met, those contractors do not themselves need a licence. Internet] UK Government.

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Safe Handling of Hazardous Drugs

RX Note

The Hidden Truth Studies have shown that the antineoplastic residues can be found be on the external packaging of both oral and IV drugs. When the NIOSH List of Hazardous Drugs in Healthcare Settings, 2023 has been finalized, it will be published to the NIOSH website.

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EU fines Teva and Cephalon €60.5m for ‘pay for delay’ scheme

pharmaphorum

Although Teva and Cephalon are now the same company, the case dates back to June 2005 when the firms were separate entities. The two companies agreed to settle the dispute but as part of the settlement Teva received a package of commercial side-deals and cash payments.

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Pharma within planetary boundaries

European Pharmaceutical Review

Giving environmental risk assessments teeth Since 2005, the authorisation of a human pharmaceutical product requires an environmental risk assessment (ERA). European Pharmaceutical Strategy – European Commission (draft) Pharmaceutical package. Internet] Berlin: Centre for Planetary Health Policy. Available from: [link].

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Before & After: Pharmacy’s Digital Revolution

pharmacy mentor

The Digital Revolution in numbers: 721 million UK Prescriptions Dispensed in 2005 (Pharmaceutical Journal). Automation , (think Prescription Collection Machines , Dispensing Robots and Packaging Machines) significantly decreases the admin, and therefore long-term expenditure on Rx work. 56 UK Online Pharmacies in 2008/9 ( Statista ).