EMA takes note of the European Ombudsman’s decision on pre-submission activities

Europe – EMA takes note of the European Ombudsman’s decision on pre-submission activities

EMA welcomes the European Ombudsman’s recognition of the value and need for scientific advice and her recommendations are in line with EMA’s ongoing initiatives to further...
MHRA launches consultation on how to best engage patients and the public

UK – MHRA launches consultation on how to best engage patients and the public

The responses will help inform the MHRA’s future engagement with patients and the public. The MHRA wants to adopt a more systematic approach to listening...
Le Plan Juncker soutient la recherche dans le traitement des maladies orphelines en France

Europe – Le Plan Juncker soutient la recherche dans le traitement des maladies orphelines...

La Banque européenne d'investissement (BEI) et la société pharmaceutique Advicenne ont signé un accord de prêt de 20 millions d'euros, soutenu par le Fonds...
NICE U-turn for Kisqali in breast cancer

UK – NICE U-turn for Kisqali in breast cancer

The decision comes just three months after the governing body issued a draft guidance rejecting the drug, citing that “it is not known whether...
Four new substances added to the Candidate List

Europe – Four new substances added to the Candidate List

ECHA has added four new substances to the Candidate List due to their toxicity to reproduction, endocrine disruption and a combination of other properties...
Dosage Form Monographs for Public Consultation

Europe – Dosage Form Monographs for Public Consultation

The European Pharmacopoeia (Ph. Eur.) Commission is undertaking a review of the mandatory dosage form monographs. As part of this process, its Group of experts 12...
Control of nitrosamine impurities in sartans: revision of five Ph. Eur. monographs

Europe – Control of nitrosamine impurities in sartans: revision of five Ph. Eur. monographs

The European Commission has issued its final legally binding decision on medicines containing valsartan, candesartan, irbesartan, losartan and olmesartan on 2 April 2019. This decision was...
Dosage Form Monographs for Public Consultation

Europe – Le format eCTD est obligatoire pour tous les dossiers de CEP...

Conformément au guide “Electronic submissions for CEP applications-Roadmap 2016-2020” un changement majeur sera mis en application à partir du 1ier janvier 2020 : • Le format...
The Human Medicines and the Medical Devices Regulations 2019

UK – The Human Medicines and the Medical Devices Regulations 2019

These Regulations, which come into force immediately before exit day, are made to correct drafting defects and omissions in the Human Medicines (Amendment etc.)...
AbbVie’s Skyrizi gets rapid ‘yes’ from NICE

UK – AbbVie’s Skyrizi gets rapid ‘yes’ from NICE

The positive Final Appraisal Document (FAD) means Skyrizi (risankizumab) is recommended for severe psoriasis treatment in adults who have failed conventional systemic therapies. The recommendation means...

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