The UK’s new International Recognition Procedure is intended to “enhance the attractiveness of the UK” by creating an environment where the pharmaceutical sector is able to develop and launch new medicines more quickly for the benefit of public health, according to Julian Beach of the Medicines and Healthcare products Regulatory Agency (MHRA).
UK Regulator On Using The New International Reliance Procedure To Encourage Filings
The MHRA says that further guidance is coming on the dossier requirements and fee levels for the new recognition procedure, and that electronic forms for determining the eligibility of submissions for the procedure will be published shortly.
More from Europe
• By
Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.
• By
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
• By
Vaccine developers should be aware that the framework underpinning the new EU Health Technology Assessment (HTA) Regulation might not be suitable for immunizations, but actions from policymakers and industry could help mitigate some issues, a senior figure from GSK says.
• By
Europe’s vaccines industry wants to make sure immunizations “are not forgotten” by policymakers who are overseeing the EU Health Technology Assessment Regulation. It has highlighted several nuances of vaccines that should be addressed over the coming years.
More from Geography
• By
The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.
• By
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
• By
US CDC’s Advisory Committee on Immunization Practices voted for harmonized meningococcal vaccine recommendations, while hearing updates about Sanofi’s pending supplemental MedQuadfi indication, AstraZeneca’s FluMist self-administration launch plans, and Lyme disease