Increased discount leads NICE to reverse positon on Clovis cancer drug

UK – Increased discount leads NICE to reverse positon on Clovis cancer drug

NICE’s final appraisal document overturns the position it reached originally. In draft guidance shared for consultation earlier this year, NICE found Rubraca ‘does not...
Elmiron bags draft NICE approval

UK – Elmiron bags draft NICE approval

The organisation recommended that the drug is used in accordance with specified considerations, as the only licensed oral medication for BPS with glomerulations or...
Supplément 10.1 de la Ph.Eur. Les titulaires de CEP sont invités à mettre à jour leurs dossiers

Europe – Supplément 10.1 de la Ph.Eur. Les titulaires de CEP sont invités à...

Les titulaires de CEP sont invités à mettre à jour leurs dossiers en conformité avec les monographies révisées qui seront en vigueur au 1er avril...
Importing medicines from the EEA after Brexit

UK – Importing medicines from the EEA after Brexit

In a no-deal Brexit existing wholesale dealers that source human medicines from an EEA State for use in the UK will need to review...
Licensing biosimilars, ATMPs and PMFs after Brexit

UK – Licensing biosimilars, ATMPs and PMFs after Brexit

If the UK leaves the EU without a deal, the MHRA will continue to regulate biosimilar products according to the same principles that are applicable now. These are...
How the MHRA will manage UK orphan medicinal products after Brexit

UK – How the MHRA will manage UK orphan medicinal products after Brexit

The MHRA will be responsible for reviewing applications from companies for orphan designation at the time of a marketing authorisation application (MAA). There is...
Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) in a no-deal Brexit, 'grandfathering' and managing lifecycle changes

UK – Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) in a...

All existing CAP MAs will automatically be converted into UK MAs and issued with a UK MA number on exit day. These UK MAs are referred to in this guidance as “converted EU MAs”. MAHs can choose...
Supplément 10.1 de la Ph.Eur. Les titulaires de CEP sont invités à mettre à jour leurs dossiers

Europe – The Eur. Ph. : pioneer of good health in Europe. “Memories of...

The Council of Europe has played a pioneering role in a number of fields, some better known to the public than others. One such...
How the MHRA will manage UK orphan medicinal products after Brexit

Europe – United Kingdom’s withdrawal from the European Union (‘Brexit’ Update)

Update: As of early October 2019, EMA's total workforce was roughly 730 which is a further 6% reduction compared to June 2019. Interim arrangements allowing staff to telework from...
Clinical Trial Regulation : Update

Europe – Clinical Trial Regulation : Update

Update: In October 2019, EMA's Management Board endorsed the six-monthly monitoring report on the development of the CTIS, which assesses the performance of the IT supplier against agreed...

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