Regulatory

The COVID-19 pandemic: European regulators respond

The COVID-19 pandemic is spreading around the world with, as of this writing, more than one million cases globally and more than 500,000 cases in Europe alone. Here we summarize how The European Medicines Agency (EMA) as well as the European Commission (EC), the Heads of Medicines Agency (HMA) and the European Center for Disease […]

Do EMA and FDA review outcomes for new active substances (NASs) align?

In order to better assure the safety and efficacy of pharmaceutical products, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have taken steps to align their activities and goals. The Centre for Innovation in Regulatory Science (CIRS) and Sanofi partner on a study to evaluate their progress to date.   The common […]

Benefits of HTA implementation in the Middle East and North Africa

Health Technology Assessment (HTA) has become one of the most anticipated regulatory advancements across the Middle East and North Africa (MENA) due to its potential to modernize healthcare systems through innovative evaluation of healthcare interventions. Stakeholders see HTA as a tool to optimize healthcare resource allocation through transparent decision making.   The current state of […]

Q&A: Five simple strategies to ensure regulatory compliance when globalizing your development program

Industry expert Lawrence Liberti shares his tips for tackling the complexity and diversity of regulatory requirements in divergent markets While expansion into new markets potentially introduces tremendous opportunities to scale your business, globalizing your development program doesn’t come without risks. Whether you’re a pharma or biotech from an established region looking to expand into an […]

Regulatory reform in China enhancing clinical trials review and approval

In order to encourage innovation, speed up access to new drugs and meet the needs of patients, an updated investigational new drug (IND) review procedure was created in China and has been in effect for just over a year. The change drew discussion at both the DIA China 2019 meeting in Beijing in May as […]

Record new drug approvals: ‘fleeting success’ or here to stay?

With a record 59 new drugs approved by the FDA and 42 new active substances recommended for authorization by the European Medicines Agency, 2018 was a profoundly productive year for biopharma. In a new analysis, Jamie Munro and Helen Dowden from Clarivate Analytics examine whether 2018 represents “a fleeting success” or if there are underlying […]

Drug development challenge: Managing CMC submissions

In the era of Breakthrough Therapy and Fast Track drug designations, chemistry, manufacturing and controls (CMC) submissions can cause delays to bring a drug to market, said Drew Barlow, vice president, regulatory affairs at Syner-G Pharma Consulting.  Companies need to provide enough information to satisfy the regulatory requirements while recognizing that providing too much information early will […]