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Food supply chains in Africa | How the pandemic has impacted

The COVID-19 pandemic has seen crises of scarcity the world over, and resources of all kinds having to be spread ever-more thinly. Job losses and wage cuts around the world have had drastic ...

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COVID-19: African unity and the opportunity for a paradigm shift

With more than 3 million cases worldwide, COVID-19 has not spared any continent. As of 14 May 2020, almost 50,000 cases of COVID-19 had been recorded across 52 countries in Africa, with...

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Will FDA be forced to implement a drug importation program?

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.”...

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Green light for therapeutic cannabis experiment in France

The French legislator has always placed strict restrictions on the use of therapeutic cannabis. But the situation and legislation are evolving in France.

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The Court of Justice clarifies the EU customs rules applicable to customs valuation

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FDA launches temporary “TRIP” program to help HCT/P sponsors gain regulatory clarity

Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless, M.D. recently announced that FDA is implementing a temporary program called the Tissue Reference Group Rapid...

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FDA issues benefit-risk framework for assessing opioid drug applications, announces public meeting

Agency seeks input on “comparative advantage” requirement for new opioids

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The European Commission releases an updated Borderline Manual for medical devices

The European Commission has updated the Manual on borderline and classification in the community regulatory framework for medical devices (Borderline Manual). The Borderline Manual is...

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Pharmaceutical Sector remains under Scrutiny of EU Competition Enforcers

On 28 January 2019, the European Commission published its Report to the Council and Parliament regarding "Competition enforcement in the pharmaceutical sector (2009-2017)" ("Report")....

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South Africa's green rush- "weeding" out the confusion

Following the recent landmark decision of the South African Constitutional Court, in which the private and personal use of cannabis was decriminalised, together with the publication of...

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The EMA has published a Concept paper for a Guideline for the development of medicinal products containing allergens to treat rare allergic diseases

On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”. Four EMA guidelines...

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EMA office in Amsterdam opened – Wooden shoes, orphan drugs and drug pricing in the context of Brexit

On 9 January 2019, the European Medicines Agency (EMA) opened its office in Amsterdam, the Netherlands. As the UK will leave the EU 29 March 2019 due to Brexit, the EMA is relocating from...

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