CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – India lifts export restrictions on paracetamol API

India has ended restrictions on export of active pharmaceutical ingredients (API) of common pain reliever paracetamol, the Directorate General Of Foreign Trade (DGFT) said...
FDA finalizes contentious guidance on third party 510(k) reviews

USA – FDA seeks input on rare disease clinical trials network

To further the establishment of a rare disease clinical trials network, the US Food and Drug Administration (FDA) is asking for input from the...

USA – FDA looks to overhaul Orange Book, seeks input on patent listings

Nearly 40 years after its creation, the US Food and Drug Administration (FDA) is looking to modernize its Orange Book, which lists patent, exclusivity and...

Europe – COVID-19: reminder of the risks of chloroquine and hydroxychloroquine

EMA is reminding healthcare professionals to closely monitor patients with COVID-19 who are receiving chloroquine or hydroxychloroquine, given the serious side effects that can...
CLASSIFICATION DES DM : Comparaison DDM/RDM

Europe – New vaccine for prevention of Ebola virus disease recommended for approval in...

EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for a new Ebola vaccine that provides active immunisation to prevent...

Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...

EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its May 2020 meeting. The Committee recommended granting a marketing authorisation for a new vaccine that...

Canada – Health Canada releases guidance to streamline COVID-19 clinical trials

Health Canada Wednesday issued two guidance documents designed to streamline clinical trials for medical devices and drugs that are related to COVID-19.   The guidance documents...

Europe – Global regulators work towards alignment on policy approaches and regulatory flexibility during...

As part of its coordinated response to the pandemic, the International Coalition of Medicines Regulatory Authorities (ICMRA) convened its regular high-level meeting of regulators from around...

Europe – European medicines regulatory network fully mobilised in fight against COVID-19

The development and availability of medicines and vaccines for all patients in the European Union, including those with COVID-19, is the number one priority...
Report from the CMDh meeting held on 17-19 September 2019

Europe – European Medicines Regulatory Network COVID-19 Business Continuity Plan

The development and availability of medicines and vaccines for all patients in the European Union, including those with COVID-19, is the number one priority...

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