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MHRA publishes guidance on medicine regulation after Brexit

pharmaphorum

The UK’s medicines regulator has published long-awaited guidance on regulation of medicines and medical devices as the UK approaches the end of its Brexit transition period at the end of the year. Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. “If

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The drug industry continues to dare regulation

World of DTC Marketing

Pfizer and Merck have chosen to designate a select few generic manufacturers to produce cheaper versions of their drugs through the Medicines Patent Pool (MPP). The post The drug industry continues to dare regulation appeared first on World of DTC Marketing.com. spending annually.

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Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict

Pharmaceutical Technology

The revision process is reviving old conflicts in the pharma industry over fair and affordable access to medicines versus Europe’s status as a competitive home for pharma innovation. EU competitiveness Moll said the legislation revisions should instead be used to make Europe more attractive to pharma companies.

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Brexit fallout continues with batch testing concerns

Pharmaceutical Technology

In principle, the deal could create new opportunities for British pharma companies – not least the chance to work under a more supportive regulatory framework. Among the negative effects that have been reported are supply chain disruptions, skills shortages, issues around market authorisation, and added costs for pharma CMOs.

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Cybersecurity in pharma: Securing the future

Pharmaceutical Technology

Pharma companies around the world have also faced similar threats , some of which have impacted national security and public health. Regulators need to work together with industry to certify hot patches to quickly fix vulnerabilities while maintaining pharmaceutical quality,” adds Fracchia.

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What can pharma companies do to get promising antimicrobials to the frontlines of drug resistance?

Outsourcing Pharma

A new report from Access to Medicine Foundation gives the advice to ensure the few promising antimicrobials in development reach patients on the frontlines of drug resistance.

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Brazil: untapped market for big pharma manufacturing

Pharmaceutical Technology

Only a limited number of international pharma companies, however, operate manufacturing sites in the country. Large Brazilian pharma companies already play a major role in distributing Covid-19 vaccines to all of Latin America. French and Italian manufacturers have two companies in Brazil.