Regulatory

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 […]

Steps taken to streamline regulatory processes in the Middle East

When the DIA’s Middle East Regulatory Conference convened in Kuwait late last year, an array of hot topics drew considerable discussion. The gathering, which brings together multiple stakeholders from multinational companies, local manufacturers and agents/distributors with representatives of health authorities from across the region, focused on verification/reliance procedures, lifecycle management, harmonization initiatives, pharmacovigilance, barcoding, serialization […]

Sublocade approval likely to be a game changer in the U.S. fight against opioid addiction

This article is a Clarivate Analytics Market Insight report, an ongoing series featuring expert reviews of hot topics in the pharma/biotech field, with analysis and discussion on the factors currently affecting the industry. Data leveraged for this analysis was gathered from Clarivate Analytics Cortellis. According to the latest National Survey on Drug Use and Health […]

The impact of the changing regulatory environment on the approval of new medicines, 2007-2016

Over the last decade, 2007-2016, convergence in approval times as well as changes in strategies of multinational pharmaceuticals have resulted in more new active substances (NASs) being internationalized, referring here to receiving marketing authorization in six major regulatory agencies, namely the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), the Japan Pharmaceuticals […]