New EU Task Force Unveils Two-Year Regulatory Roadmap to Mitigate Medicine Shortages

Europe – New EU Task Force Unveils Two-Year Regulatory Roadmap to Mitigate Medicine Shortages

Regulatory authorities in the European Union (EU) have set up a task force to improve the availability of medicines by mitigating potential shortages based...
Stem cell-based Parkinson's therapy tested in Japan

Japan – Stem cell-based Parkinson’s therapy tested in Japan

Japanese researchers said on Friday (Nov 9) they have transplanted stem cells into the brain of a patient in the first stage of an...
Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) : Questions & Answers

Europe – Guideline on the quality of water for pharmaceutical use

Water is one of the major commodities used by the pharmaceutical industry. It may be present as an excipient or used for reconstitution of...
NICE ‘OK’ for Lynparza

UK – New NICE guidelines on antibiotic prescribing for pneumonia

The new guidelines advise that antibiotics should be given to people with community- and hospital-acquired pneumonia within four hours of establishing a diagnosis. It also...
FDA Encourages Inclusion of Older Patients in Cancer Trials

USA – Industry Groups Debate FDA’s Approach to Interchangeable Insulin Products

Branded and generic drugs industry groups are sparring over the US Food and Drug Administration’s (FDA) approach to regulating biosimilar and interchangeable insulin products...
Trois nouvelles guidances du MDCG en Mars 2020

Europe – EU agencies seek to develop common standards for medicine ePI

The European Medicines Agency (EMA), Heads of Medicines Agencies (HMA) and the European Commission on Wednesday released a set of principles for a harmonized...
Checklist for sponsors applying for the transfer of Orphan Medicinal Product (OMP) designation

Europe – EMA : Information package for certificates of medicinal products

The purpose of a certificate of a medicinal product (CMP) is to confirm the marketing authorisation status of the medicinal product and that the...

Europe – International regulators provide guiding principles for COVID-19 clinical trials

EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International Coalition of Medicines Regulatory Authorities (ICMRA). Medicines regulators from around...

USA – FDA finalizes insanitary conditions guidance for compounders

Eight years after a fungal meningitis outbreak linked to the New England Compounding Center killed dozens of patients across the country, the US Food...

Australia – Medicine packaging definitions for sponsors

Packaging terms are important to know to ensure sponsors and manufacturers are following the rules when labelling their medicines. Therapeutic goods legislation, GS1 General...

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