Regulatory & compliance

Simplification of registration procedure for French person responsible for pharmacovigilance

Eveline Van Keymeulen

In February 2020, the French National Agency for Medicines and Health Products Safety (ANSM) announced that it had set up a new portal on its website, accessible from 1 March 2020, allowing the electronic registration of persons responsible for pharmacovigilance (RPVs) in France. The registration was previously carried out through email or post. Under Article Read More

Belgium – New Bill on allowing access to confidential agreements between government and pharmaceutical companies

Tine Carmeliet

As in several other European countries, Belgium has a system in place to allow the temporary use of certain innovative medicines on the Belgian market when no reimbursement decision has been taken due to the therapeutic effectiveness of the medicine not yet being proven. This system of “managed entry agreements” is institutionalised through the so-called Read More

On-going debate on new French Bill regarding online sale of medicines

Eveline Van Keymeulen

On 5 February 2020, the French government introduced a wide-ranging Bill to the Senate, entitled “the acceleration and simplification of public action”, which deals with a variety of matters, including new provisions on e-commerce for medicinal products (Article 34). Currently, the online sale of medicines is highly regulated in France: only medicinal products that can Read More

China’s life sciences industry remains opportune despite Covid-19 coronavirus

David Shen

  While the novel Covid-19 coronavirus is at the top of the agenda for businesses around the world, and for good reason, it is creating challenges for medical and healthcare systems and signalling fundamental change across the life sciences industry. Activity in China’s life sciences market remains high as one of the few sectors to Read More

French ANSM establishes accelerated procedures for Covid-19 treatments and issues FAQ for on-going clinical trials

Eveline Van Keymeulen

The French National Agency for Medicines and Health Products Safety (ANSM) recently announced the set-up of accelerated procedures for the assessment of Covid-19 treatments that are currently being developed.  However, no further details regarding this accelerated procedure are publicly available. In the context of the pandemic, clinical trials for other treatments taking place in French Read More