Regulatory

How regulation, innovation, quality and access are inevitably intertwined

In a global industry like pharmaceuticals, the interdependencies among quality, access, innovation and regulation can have global implications. That message comes through clearly in the 2018 CPhI Annual Report, the compilation of expert forecasts and analyses that the organization puts together. The articles, with their focus on the future direction, technologies, opportunities and threats in […]

Algeria, Morocco and Tunisia changing their regulatory landscape?

Algeria, Morocco and Tunisia have fantastic potential for development in the pharmaceutical sector but weaknesses in some aspects of the pharma regulatory system create barriers to market access. Conscious of this, regulatory authorities in the region say they are determined to improve regulatory processes to allow faster access to market for essential and innovative medicines. […]

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 […]

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 […]

Green light to market Hemlibra for hemophilia A with inhibitors in the US

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.   Roche Holding’s Hemlibra (emicizumab-kxvh) has been approved in the U.S. for routine prophylaxis to prevent or reduce the frequency of bleeding […]

Accelerating – and maintaining – drug approvals in the U.S.

Bringing a drug to market is the ultimate milestone for any pharmaceutical firm that has invested significant effort, not to mention time and resources, into developing its product. But all that work and outlay does not stop at marketing approval—this achievement must be maintained. There can be various regulatory requirements that a firm must meet […]

The shifting regulatory landscape impacts the review of new medicines

Major improvements in the regulatory environment in the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) countries over the last decade has led to a decrease in the time to approval as well as an increase in the number of medicines that have become available.

Innovation comes with hefty price tag as biopharma R&D spend climbs

To keep biopharmaceutical innovation churning requires mountains of cash. Companies will need to invest as much as $2.5 billion over a 10- to 15-year period in order to bring a new therapy to the marketplace, according to a 2014 study conducted by the Tufts Center for the Study of Drug Development.