France – Le Cabinet WHITE-TILLET recrute un consultant, docteur en pharmacie ou ingénieur

Le Cabinet WHITE-TILLET recrute un consultant, docteur en pharmacie ou ingénieur, ayant une bonne connaissance de la réglementation et de l’assurance qualité des DM....
NICE Onpattro approval puts Alnylam back in hATTR running

UK – Report finds NICE’s routine appraisals need reform

The findings show that routine availability of new medicines was "delayed or prevented entirely due to an inflexible, inappropriate assessment processes". According to the report,...
When to Submit an ANDA vs. a 505(b)(2)? FDA Explains

India – Indian regulators tweak drug trial rules

The latest set of clinical trial rules, likely to be notified in March, will fast-track proposal clearances for Indian companies rather than their multinational...
Clinical trials on medicinal products submitted to the ANSM as part of the FastTrack procedure

France – Clinical trials on medicinal products submitted to the ANSM as part of...

Making health innovation accessible faster for patients is a priority that the government has posted in the CSIS 2018 (Strategic Council of Health Industries)...
Current Good Manufacturing Practice for Medical Gases Guidance for Industry

USA – Regenerative Medicines: FDA Finalizes Guidance on Expedited Programs

With almost 80 regenerative medicine advanced therapy (RMAT) designation requests in 2017 and 2018, it’s clear that the US Food and Drug Administration’s (FDA)...
Widening the availability of naloxone

UK – Widening the availability of naloxone

Regulations introduced in 2015 and amended in 2019 widened the availability of naloxone, a medicine which reverses the effects of a heroin (or other...
EMA suspends fenspiride medicines due to heart rhythm risks

Europe – EMA suspends fenspiride medicines due to heart rhythm risks

The decision is based on recent nonclinical studies (hERG channel binding and in vitro animal model studies) that showed that fenspiride has the potential to increase...
FDA Drafts Guidance on Enhancing Diversity in Clinical Trial Populations

USA – Competitive Generic Therapy Designations: FDA Explains Process in New Draft Guidance

The US Food and Drug Administration (FDA) on Friday released draft guidance providing information on how sponsors can apply for competitive generic therapy (CGT)...
Chinese NMPA update: eRPS, predicate device data, technical review guidelines

China – China plans to reduce VAT for rare disease therapies

An executive meeting of China’s State Council outlined plans to reduce the value-added tax on domestic and imported rare disease drugs, improve cancer treatment...
Implementing the Falsified Medicines Directive: Safety Features

UK – Advertise your medicines

Overview You can advertise any over-the-counter medicine, including pharmacy medicines, to the general public. You can’t advertise prescription-only medicines (POMs) to the general public but you...

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