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Category: Press

The latest updates published by the pharmaceutical industry’s regulatory bodies.

Addressing the world’s most pressing health challenges

Posted at 12:08 on October 31st, 2019 in International, Press, Regulation

The World Health Organisation (WHO) Digital Health Technical Advisory Group has agreed an action plan to focus its activities and priorities on advancing the digital health ecosystem whilst safeguarding the misuse of people’s data and protecting their health. Read more “Addressing the world’s most pressing health challenges” →

CHMP recommends granting a conditional marketing authorisation for world’s first Ebola vaccine

Posted at 15:58 on October 21st, 2019 in EMA, International, Press

“This is an important step towards relieving the burden of this deadly disease” said the European Medicines Agency’s (EMA) Executive Director. Read more “CHMP recommends granting a conditional marketing authorisation for world’s first Ebola vaccine” →

How would an international price index (IPI) work to lower drug prices in the US?

Posted at 14:48 on September 25th, 2019 in Generics, Industry news, Press

House speaker Nancy Pelosi has unveiled a plan to lower sky-high prescription drug prices in the United States (US). Read more “How would an international price index (IPI) work to lower drug prices in the US?” →

Highlights from the September CHMP meeting 2019

Posted at 09:38 on September 23rd, 2019 in EMA, Medicinal product, Press

From their meeting in September, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the September CHMP meeting 2019” →

Opioid Expert Working Group meets at MHRA

Posted at 13:52 on February 13th, 2019 in Medicinal product, Press

At the Medicines and Healthcare products Regulatory Agency (MHRA), an Expert Working Group (EWG) of the United Kingdom’s (UK’s) Commission on Human Medicines (CHM) met to begin reviewing the benefits and risks of opioid medicines, which includes dependence and addiction. Read more “Opioid Expert Working Group meets at MHRA” →

Regulis Article Published in Regulatory Rapporteur

Posted at 09:53 on May 10th, 2013 in Press

Amy Whyte and Kim Wharton wrote an article for the May edition of Regulatory Rapporteur titled ‘A Guide to Legal Status Switches in Europe’.

Recent posts

  • European Commission Decision Reliance Procedure provides a new route to obtain marketing authorisations in Great Britain
  • European Commission temporarily allows notified bodies to perform remote audits
  • EMA publishes second issue of their Clinical Trials Information System (CTIS) Highlights newsletter
  • MHRA release guidance on the decentralised and mutual recognition reliance procedure for marketing authorisations
  • The latest MHRA guidance surrounding clinical trials and Brexit

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