Medical cannabis in Europe is not covered by a harmonised regulatory framework. However, Arriello director of drug safety, Peter Kohut, argues that this should not deter pharma companies from pursuing this increasingly attractive opportunity.

Major global cannabis exporters cannot tap into a common regulatory pathway to European markets. Cannabis is a massive opportunity, but marketing cannabis products in the diverse European market is a complex challenge, writes Arriello Director of Drug Safety Peter Kohut.

Gabriela Marton, Regulatory Affairs Director and Quality Director at Arriello, highlights EU regulatory challenges and calls for policy changes and education to maximize the opportunity for biosimilars to enhance patient outcomes.

The European medical cannabis market lacks a common regulatory framework; Peter Kohut charts a route through the complexity and highlights opportunities for the taking.

Medical cannabis is a growing market in Europe – but there is a lack of the usual regulatory framework intended to harmonise marketing of medicines and keep them safe. Arriello Director of Drug Safety Peter Kohut provides a guide to marketing cannabis products in the diverse European market.

There is considerable variation in the regulatory approach to medical cannabis between European countries. Yet, despite the complexity, there are clear routes to market, reports Peter Kohut.

Biosimilars provide cost-effective alternatives to biological drugs and represent a growing opportunity. However, Europe lacks a harmonised regulatory approach.

Gabriela Marton sets out some of the EU-associated regulatory challenges life sciences companies will need to navigate if they want to take advantage of the rise of biosimilars. Biosimilar treatments offer similar benefits for the healthcare system as generic drugs, although they cannot be compared.

Writing for IPI Media World Arriello's Vanessa Fachada Oliveira on why so many Pharma companies are failing their regulatory audits

The coronavirus has had an enormous impact on European regulatory activity. To ease the strain and maintain vital supplies, the European Commission, European Medicines Agency, and Heads of Medicines Agencies published updated guidance in April, including new flexibility and simplified and accelerated authorisation procedures.